Overview

The Project Manager, Regulatory Affairs, plays a pivotal role in driving APACMed's Regulatory Affairs (RA) agenda across the Asia-Pacific region. The position involves managing complex RA initiatives, fostering collaboration among stakeholders, and ensuring the successful delivery of high-impact projects aligned with the association’s strategic goals. This role requires a proactive mindset, and the ability to navigate and influence policies that enhance patient access to innovative medical technologies.

Key Responsibilities

Committee Agenda and Leadership:

• Lead the development and execution of the RA Committee's agenda, ensuring alignment with APACMed’s broader strategic priorities.
• Spearhead workstreams and initiatives within the RA Committee’s purview, from inception to completion.
• Collaborate with senior members to define project objectives and craft actionable plans to deliver measurable outcomes.

Stakeholder Engagement and Collaboration:

• Build and maintain relationships with key stakeholders, including regulators, policymakers, healthcare providers, and industry leaders, to advance committee goals.
• Serve as a primary liaison between APACMed members and external partners to ensure alignment and effective communication.

Policy Advocacy and Regulatory Harmonization:

• Lead the drafting of position papers, advocacy materials, and white papers to address regulatory gaps and opportunities.
• Represent APACMed in regulatory discussions to advocate for harmonized, patient-focused regulatory practices across the region.

Project Management:

• Manage multiple RA initiatives simultaneously, ensuring that timelines and deliverables are met with precision.
• Oversee project budgets, milestones, and stakeholder expectations to drive successful outcomes.
• Provide operational support for key APACMed regulatory initiatives, including SaMD, e-labeling, and post-market surveillance.

Event Planning and Coordination:

• Organize and execute RA-focused workshops, roundtables, and forums, managing all aspects of event logistics, speaker engagement, and post-event documentation.
• Develop summary reports and insights from events to share with stakeholders and members.

Regulatory Intelligence and Analysis:

• Monitor and analyze regulatory developments across APAC markets, compiling insights to inform strategic priorities.
• Provide actionable recommendations to the RA Committee and APACMed leadership based on trends and emerging issues.

Qualifications and Skills

Educational Background:

Advanced degree in Biomedical Sciences, Medical Sciences, Regulatory Affairs, Public Health, Health Policy, or a related medical/scientific discipline.

Experience:

• Minimum of 5 years of professional experience in regulatory affairs, policy advocacy, healthcare strategy, or a related field, with a preference for regional roles in the MedTech or broader healthcare industry.
• Candidates with regulatory affairs experience or a background in medical sciences/consultancy are encouraged to apply.
• Proven track record of managing cross-functional projects and engaging with diverse stakeholder groups.

Skills and Competencies:

• Strong project management and organizational skills, with an ability to juggle multiple priorities in a fast-paced environment.
• Exceptional analytical and writing capabilities to produce high-quality policy documents and reports.
• Excellent communication and presentation skills, with the ability to articulate complex regulatory concepts clearly and concisely.
• Knowledge of global and regional regulatory frameworks in MedTech, including SaMD and e-labeling.
• Proficiency in Microsoft Office tools, project management software, and data visualization platforms.

Personal Attributes:

• Independent and self-motivated, with a strong sense of accountability.
• Collaborative team player who can work effectively across cultures and organizational hierarchies.
• Proactive problem solver with meticulous attention to detail.

Working at APACMed

This position offers unique opportunities to work closely with senior leaders from the world’s largest MedTech companies, as well as regulators and stakeholders across the region. The role provides exceptional visibility within the industry, fostering professional growth and meaningful impact in shaping the regulatory landscape in APAC.

Key Responsibilities:

Key activities will revolve around leading regulatory activities for both the diagnostic agent, camera and cloud base platform across the specified region.

• Preparation and delivery of high-quality regulatory submissions and submission management plans for global regulatory agencies.
• Independently prepare regulatory submissions and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and work to support the product portfolio.
• Managing regulatory issues, maintaining submission information in relevant systems, tracking regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
• Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.
• Authoring and/or coordinating submission activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinating and contributing to responses to agency queries and performing quality review of regulatory submissions.
• Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by products.
• Assisting the Manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
• Maintenance of existing global regulatory approvals.
• Prioritizing and independently completing assigned workload appropriately.
• Managing and contributing to regulatory affairs-related projects, initiatives and actions.

Experience and Capabilities:

• Bachelor's degree or equivalent/graduate degree preferred in a science (Biology, Chemistry, Pharmacy or related science) and/or technical discipline.
• Minimum of 5 years of hands-on Regulatory/Chemistry, Manufacturing and Controls (CMC) authoring experience preferable (initial registrations or post-approval variations).
• Experience managing projects is preferable.
• Excellent verbal, written and presentation skills.
• Knowledge of local market dynamics and business practices in Asia.

Core Competencies / Attributes:

• Action and results-orientated to achievement of goals and objectives.
• Experience with leading and participating in several projects concurrently.
• Ability to accurately scope projects and consider the full impact of decisions and actions taken.
• Excellent interpersonal skills and ability to participate with cross functional teams in projects and innovation.
• Strong presentation skills, able to engage people in technologies, products & services.
• Functional expert in regulatory affairs with a passion for excellence.
• Attention to detail and accuracy – essential.
• Maintains direction & focus through proactive planning & organized approaches to work.
• Resilient to objections, pressure and change in a fast-moving industry.

Medical Affairs Manager/Director - Biopharmaceutical

Role Summary

We are seeking an experienced Medical Affairs profile to lead our medical affairs initiatives across Southeast Asia. This senior role involves driving regional strategies, building relationships with healthcare professionals, leading the medical science liaisons (MSL’s) and serving as a key representative in advancing scientific and medical excellence. You will be responsible to align local medical plans with global objectives to support the organisation’s mission for 2025 and beyond.

The Opportunity

This position offers the chance to make a meaningful impact on healthcare in the region. You will:

• Develop and execute medical affairs strategies that align with global goals.
• Lead a team of MSLs, supporting their growth and optimising performance.
• Build relationships with thought leaders and the broader medical community.
• Plan and oversee scientific events, including advisory boards, webinars, and symposiums.
• Represent the organisation at regional and global medical affairs meetings and conferences.
• Drive regional research initiatives, such as investigator-sponsored studies and educational grants.
• Collaborate with regulatory, market access, and patient advocacy teams to address country-specific needs.
• Ensure compliance with regulations while managing budgets effectively.

What We’re Looking For

• A degree in Biology, Biotechnology, Pharmacy, or Medicine; a PhD, MD, or similar is highly desirable.
• 7 – 12+ years of experience in medical affairs, preferably within the pharmaceutical or biopharmaceutical industry.
• Advanced knowledge of medical and pharmaceutical sciences, coupled with ethical and scientific integrity.
• Strategic thinking, relationship-building, and communication expertise.

What’s on Offer

• Competitive salary - ranges depending on experience
• Benefits package
• International team
• Improving patient outcomes and advancing healthcare innovation

What’s Next

If this opportunity excites you and aligns with your expertise, we encourage you to apply.

Send your updated CV to [email protected]highlighting your relevant experience. We look forward to exploring how your expertise can contribute to transforming healthcare in the region.

Please note: Due to high application volumes, we may not be able to respond to every applicant. If you do not hear from us, please consider your application unsuccessful at this time. We encourage you to apply again in the future.

Engage Group Life Science – Singapore & Southeast Asia
[email protected]

• Company: Dairy and Nutritional Product
• Location: Jurong East (Nearest MRT Station)
• AWS + Variable Bonus
• WFH (Once a week)

Job Description:

• Ensure regulatory compliance for the company’s products in the B2B segment, and develop regulatory strategies to achieve product registrations and business goals in the APAC region in a timely manner.
• Represent the company in relevant professional associations and regulatory agencies; participate in government agency inspections as needed.
• Maintain a comprehensive understanding of the company’s product portfolio.
• Liaise and negotiate with relevant regulatory authorities and agencies.
• Stay updated on changes in regulatory legislation and guidelines.
• Visit customers with the sales team to explain relevant regulatory frameworks and information; attend industry shows and meetings.
• Coordinate and conduct training sessions for company employees on new regulatory topics.
• Collaborate with other departments, including the B2B sales team, headquarters in Japan, and other company entities in the US, EU, and Asia, as necessary.
• Communicate with key contacts at the headquarters in Japan to obtain necessary data for customer reports or projects.
• Review and approve marketing and sales materials to ensure compliance with regulatory requirements.
• Perform any other ad hoc duties as assigned.

Job Requirements:

• Experience with Salesforce: Use a minimum number of years on Salesforce.
• Education: Minimum of a Bachelor’s Degree in Food Science, Nutrition, or related fields with 3+ years of relevant regulatory experience.
• Technical Skills: Ability to independently design and execute regulatory projects.
• Interpersonal Skills: Excellent interpersonal and networking abilities to build strong relationships with trade and regulatory associations.
• Customer Orientation: Customer service-focused and able to work effectively with diverse personalities.
• Regulatory Knowledge: Familiarity with food safety regulations.
• Familiarity in Functional ingredients (E.g. Probiotics, Peptides etc.) is a plus

Interested applicants please apply directly for further shortlisting review.

We regret that only shortlisted candidates will be notified. Other applications will be updated to our database for future job opportunities.

By submitting any resumes or applications to Pasona Singapore Pte Ltd, you are considered to have read and agreed on the terms of our Privacy Policy, and consented to us collecting, using, retaining, disclosing your personal information to the prospective employers for their consideration.

Effective from 1 October 2020 under the new Employment Agencies (EAs) Licence Conditions,

EAs will be required to collect the personal data (e.g. NRIC number number for overseas candidates) of applicants referred to employers for permanent or contract job positions of at least six months with a fixed monthly salary of S$3,300 and above.

PDPA requirements on collection, use, and disclosure of personal data would not be applicable to EAs that are collecting such information as it is a regulatory requirement by Ministry of Manpower.

Please find Privacy Policy Agreement from the below link.

http://www.pasona.com.sg/privacy.html

Jeffrey Koh Kok Ann

EA Registration No: R1770345

Pasona Singapore Pte Ltd

1 FINLAYSON GREEN ＃09-02 SINGAPORE 049246

EA License No:90C4069

Industry: Food Nutrition

Job position: Regulatory Affairs Assistant Manager/Manager Job ID: 19431

Hybrid working arrangement (1 day wfh)

Key Responsibilities:

- Ensure regulatory compliance for the company’s products in the B2B segment, and develop regulatory strategies to achieve product registrations and business goals in the APAC region in a timely manner.
- Represent the company in relevant professional associations and regulatory agencies; participate in government agency inspections as needed.
- Maintain a comprehensive understanding of the company’s product portfolio.
- Liaise and negotiate with relevant regulatory authorities and agencies.
- Stay updated on changes in regulatory legislation and guidelines.
- Visit customers with the sales team to explain relevant regulatory frameworks and information; attend industry shows and meetings.
- Coordinate and conduct training sessions for company employees on new regulatory topics.
- Collaborate with other departments, including the B2B sales team, headquarters in Japan, and other company entities in the US, EU, and Asia, as necessary.
- Communicate with key contacts at the headquarters in Japan to obtain necessary data for customer reports or projects.
- Review and approve marketing and sales materials to ensure compliance with regulatory requirements.

Requirements:

• Experience with Salesforce: Use a minimum number of years on Salesforce.
• Minimum of a Bachelor’s Degree in Food Science, Nutrition, or related fields with 3+ years of relevant regulatory experience.
• Ability to independently design and execute regulatory projects.
• Excellent interpersonal and networking abilities to build strong relationships with trade and regulatory associations.
• Customer service-focused and able to work effectively with diverse personalities.
• Familiarity with food safety regulations.

Interested applicants please send your resume to [email protected] with email subject header “Job Application for Regulatory Affairs Assistant Manager/Manager Job ID: 19431- CK".

We regret that only shortlisted candidates will be notified. Other applications will be updated to our database for future job opportunities.

By submitting any resumes or applications to Pasona Singapore Pte Ltd, you are considered to have read and agreed on the terms of our Privacy Policy, and consented to us collecting, using, retaining, disclosing your personal information to the prospective employers for their consideration.

Effective from 1 October 2020 under the new Employment Agencies (EAs) Licence Conditions,

EAs will be required to collect the personal data (e.g. NRIC number number for overseas candidates) of applicants referred to employers for permanent or contract job positions of at least six months with a fixed monthly salary of S$3,300 and above.

PDPA requirements on collection, use, and disclosure of personal data would not be applicable to EAs that are collecting such information as it is a regulatory requirement by Ministry of Manpower.

Please find Privacy Policy Agreement from the below link.

http://www.pasona.com.sg/privacy.html

Koh Siew Xing

EA Registration No: R22104418

Pasona Singapore Pte. Ltd.

EA License No:90C4069

About Us

Vivo Surgical is a patient-focused, clinician-driven medical device developer and manufacturer. Headquartered in Singapore with offices in China and Thailand, we are pioneering a novel endoscopic surgical robot for complex endoluminal surgeries. ISO 13485 certified with international accreditations awarded such as the US FDA and European CE mark, our devices target the medical needs of the world through innovative applications of science & technology. These encompass such fields as in vivo surgical LED lighting, portable endoscopy and endoscopic robots, which are strategically co-developed with world-class healthcare institutions and KOL collaborators. Join us as we build towards our vision of being Asia Pacific’s leading medical device developer and manufacturer.

About The Role

We value the importance of having a robust Quality Assurance and Regulatory Affairs team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Quality Assurance & Regulatory Affairs Manager to join us on this journey. You will be part of our fast-growing team and will take ownership of your role from the get-go. You will work on ensuring our company’s commitment to comply with regulatory requirements and to maintain the effectiveness of our Quality Management System (QMS). You will also be in charge of our products’ regulatory strategies and submissions to various regulatory bodies. Your role will enable you to work not only with diverse functions internally but also in close tandem with our external partners such as our suppliers, distributors and notified bodies.

Your responsibilities shall include the following:

• Ensure the company’s QMS complies with ISO 13485 and FDA 21 CFR 820/QMSR.
• Develop and manage Quality Procedures such as document control, CAPA, NCR, Supplier Control, Production Control, Feedback and Complaints Handling, and Post Market Surveillance.
• Organize and execute internal audits, management reviews and supplier audits.
• Plan and lead ISO 13485 audits and regulatory inspections.
• Participate in the products’ verification and validation activities.
• Develop, review and compile the medical device technical files whilst making sure the products meet all regulatory and quality standards.
• Involved in risk assessment tasks to identify potential quality and compliance risks in the product lifecycle and advise adequate risk control measures.
• Serve as the company’s Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC).
• Manage and mentor the QARA team to ensure members are adequately trained.
• Stay updated on medical device laws and regulations in the targeted markets.
• Work with senior management to define and deliver adequate quality and regulatory strategies.

Your Qualifications & Experience

• Minimum Bachelor’s degree in Engineering or Science.
• At least 5 years’ experience in quality assurance and/or regulatory affairs in the medical device Industry.
• Firm understanding of ISO 13485:2016, FDA 21 CFR 820/QMSR and ISO 14971.
• Prior involvement in HSA, FDA 510(k)/De Novo and/or MDR 2017/745 submissions will be a plus.
• Experience in generating risk management documentation (risk management plan, report, FMEAs).
• Possess a leadership and strategic mindset to organize and prioritize tasks for effective and timely delivery of regulatory goals to meet the company’s business objectives.
• Certification as an ISO13485:2016 lead auditor will be advantageous.

Contact

Please send your CV and cover letter to: [email protected]. We look forward to receiving your application.

PRODUCT COMPLIANCE TO LOCAL REGULATIONS:PRODUCT COMPLIANCE TO LOCAL REGULATIONS:

• Manage the regulatory activities across Southeast Asia region - regulatory submissions, ensure compliance for new or existing products.
• Develop and implement regulatory strategies to ensure compliance with all relevant laws, regulations, and guidelines.
• Manage the preparation of regulatory submissions, including product registrations, licenses, and approvals for new and existing products.
• Draft, revise and review the relevant submission documents.
• Provide regulatory guidance for the labelling, formula compliance, advertising and marketing of new and existing products across Southeast Asia region sales channels.
• Conduct regulatory assessments and evaluations of product formulations, labelling, and promotional materials to ensure compliance.
• Review raw material and ingredient compositions for regulatory conformity based on industry guidelines.
• Participate in the design of new product launches by providing regulatory expertise on product formulation, package design, labelling, and claims development, etc.
• Create and/or update document standard operating procedures regulatory activities.
• Develop and implement procedures for creating, reviewing and approving labels to ensure consistency in labelling in the Southeast Asia markets.
• Support product notifications as per business needs ensuring supply continuity.

MANAGING EXTERNAL REGULATORY/ GOVERNMENT BODIES/ CUSTOMS:

• Provide responses to regulatory agencies regarding product information or issues.
• Assist with activities such as audits, regulatory agency inspections, or product recalls.
• Develop relationships with various regulatory agencies, as required.
• Assist with investigations relative to product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Manage and track labelling projects across Southeast Asia region, including a system to provide access to important documents to external stakeholders.
• Assist in creation of responses to regulatory agencies regarding product information or issues.
• Securing documentation from various government agencies across the Southeast Asia region on an as needed basis.
• Create product certificates and product documentation for product notification/registration where necessary.
• Act as a HSA Agent for a foreign establishment to (a) review, disseminate, route, and respond to all communications from HSA including emergency communications; (b) respond to questions concerning those drugs that are imported or offered for import to HSA; (c) assist HSA in scheduling inspections; and (d) If HSA is unable to contact a foreign registrant directly or expeditiously, HSA may provide the information and/or documents to the HSA agent. HSA’s providing information and/or documents to HSA agent is equivalent to providing the same information and/or documents to the foreign registrant.
• Attend project meetings at early or late time of the day to accommodate external clients or internal customers located at different time zones.
• Communicate with client/sponsor as needed.

NEW PRODUCT INTRODUCTION SUPPORT:

• Involvement in project implementation from regulatory perspective for new product introductions.
• Support relevant team on creating new product pipelines and launches products according to project timelines.
• Work closely with cross functional teams to ensure required documentation and compliance evaluations are in place for successful product registration/notification and launch.
• Provide regulatory guidance to departments or development project teams regarding appropriate subjects.

CONTINUOUS IMPROVEMENT:

• Stay abreast of changes in regulatory requirements and industry trends to proactively advise the company on regulatory matters.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Provide training session to the global RA team of Southeast Asian Regulations related to drug registration.
• Maintain good relationship with other functional departments.
• Key Challenges and Success Measures Customer, Stakeholders and Sourcing Site Regulatory Collaboration: Communicate regulatory information to cross-functional teams and ensure that information is interpreted correctly.
• Extend support to customers in case of product clearance/customs as needed.
• Provide accurate, risk-based approach to regulatory queries.
• Positively add to the culture of the organization and participate across the broad spectrum of activity the function is responsible for to deliver on the total organizational goals.
• Responsive to stakeholders.
• Assist routine management of RA department or temporary works assigned by RA Director.

REQUIREMENT:

• Familiarity with relevant regulatory guidelines and standards.
• Possess good knowledge of local and Southeast Asia regulations, inclusive HSA, USFDA, TGA, etc guidance.
• Good interpersonal and communication skills.
• Good organization and coordination capability, characterized with sense of responsibility, acceptable and adaptable to work pressure, endurable to hardship.
• Bilingual in both English and Mandarin (including read, speak and write).
• A good team player with positive learning attitude.
• Independent, meticulous, detail-oriented, and proactive.
• Detail-oriented with the ability to manage multiple projects and deadlines effectively.
• Ability to work collaboratively in a team environment and communicate effectively with internal and external stakeholders across multiple time zones and cultures
• Strategic thinker with the capability to adapt to changing regulatory landscapes and business needs.
• Results-driven mindset with a commitment to upholding high ethical and professional standards.
• Strong management skills.
• Strong ability to research, analyse, problem solving and project management.

EDUCATION & EXPERIENCE:

• Experience of 5 years or above of drug development and/or related experience in pharmaceutical/biopharmaceutical/medical, and 3 years or above on working with regional / country specific regulatory bodies, customs, regulatory consultants, etc.
• At least bachelor’s degree studies from an accredited college/university, preferably in Medicine/Pharmacology/Pharmacy/Chemistry/Pharmaceutical Sciences discipline or related field.
• Preferably holds a valid Pharmacist license with Singapore Pharmacy Council.

Candidates are encouraged to apply this position via email to [email protected] with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

Job Description

• Full awareness of local Health Products and Medical Device Act and their regulations relevant to the business through regularly checking HSA websites and attending HSA briefings;
• Communicate changes and new requirements to management;
• Request and submit documents for product registration and amendments applications;
• Follow up on submitted applications and reply input requests from the authority;
• Meet, discuss and negotiate with HSA regulators on matters pertaining to product registrations;
• Have working knowledge of current products sold and keep abreast of new product launches by having regular update meetings with all the selling division managers;
• Assist Senior Manager, Regulatory Affairs for matters pertaining to regulatory affairs as and when required;
• Communicate with manufacturers, the local regulatory requirements, in order to facilitate the provision of appropriate documents for submission to HSA for product registration/amendments and compliance to local regulations;
• Work with regulatory partners/distributors to obtain successful registration of new products.
• Coordinate, facilitate, monitor, and track all regulatory activities in each market,
• Comply with reporting requirements of local authority
• Regulatory reporting for recalls, FSCAs, Adverse Events and complaint handling;
• Ensure compliance with GDPMDS;
• Ensure conduct of business according to local regulations for medical devices;
• Participate in GDPMDS internal and external audits
• Maintain and update regulatory-related databases, SOP
• Registers complaint with samples to manufacturer. Follow-up on reply from manufacturer.
• Any other duties assigned

Job requirement

• General Degree (preferred in discipline of Biomedical Science or Biomedical Engineering)
• Preferred 1 year working experience or completion of Internship in the related field
• Familar with local and regional regulatory affairs requirements (medical devices)

Personal Competencies:

• Good interpersonal relationship skills
• Good written and verbal communication skills
• Project Management Skills
• Good organization skills
• Team spirit, Proactive, motivated, self starter

Job Descriptions:

• Ensure smooth daily administration and operation of the office.
• Planning and implementing the global administrative and general affairs management system, including the establishment of various standard forms, meeting SOP, introduction, and teaching of clerical tools, etc.
• Upkeep cleanliness and maintenance of facilities including liaising with vendors, upkeep of first aid supplies and fire-fighting equipment, ensuring reception and meeting rooms readiness at start and end of day.
• Record and update office inventory, ordering of stock.
• Manage procurement and replenishment of office, centers’ required consumables, stationery, and supplies.
• Provide logistics support such as room booking, prepare beverages, projector etc.
• Diary management and arranging appointments, booking meeting rooms and conference facilities.
• Other duties as assigned by Senior Management.

Job Requirements:

• 3-5 years relevant experience, such as co-working or sharing office management experience.
• With developed global administrative affairs, property management capabilities and SOP establishment experience is a plus.
• With project management experience is a plus.
• With office renovation experience is a plus.

We Are Kemin

We are visionaries who see things differently and are inspired by the world around us. We have been dedicated to using applied science to improve the quality of life for over half a century. Committed to feed and food safety, Kemin maintains top-of-the-line manufacturing facilities where over 500 specialty ingredients are made for humans and animals in the global feed and food industries, as well as the health, nutrition, and textile markets. We provide product solutions and options to customers in more than 120 countries.

A privately held, family-owned and operated company, Kemin has more than 3,000 global employees including manufacturing facilities in Belgium, Brazil, China, India, Italy, Russia, Singapore, South Africa and the United States.

RESPONSIBILITIES:

• Manages regulatory projects registrations, including preparation of registration dossier, submission and follow up with regulatory authorities
• Maintains and renews existing product licenses
• Keeps up to date with changes in regulatory legislation and guidelines in Asia Pacific countries assigned and sharing the information within the organization
• Interprets and provides regulatory guidance to cross functional team including manufacturers, scientists and marketing and sales colleagues
• Reviews labels, marketing materials for accuracy and regulations compliance
• Manages and support regulatory operational work assignments
• Responds to customers’ requests and resolves issues regarding regulations and compliance matters
• Supports the RA functional Head in various other activities as assigned
• Studies and interprets related scientific and legal documents for regulatory applications
• Writes comprehensible and clear product information leaflets
• Offers advice about company policies, practices and systems
• Liaises and negotiates with regulatory authorities for registration applications
• Ensures that company’s Intellectual properties are protected

QUALIFICATION:

• Degree/Diploma in Science (Biochemistry/ Chemistry/Microbiology/Food Science/ Biotechnology/ biomedical science/ Pharmaceutical science etc.) or equivalent

SKILLS & EXPERIENCE:

• 3 years of regulatory experience is preferred.
• Animal feed additive registration experience is a plus.
• Self-motivated and meticulous with good organizational, negotiation skills
• Must have high level of integrity to handle confidential company information
• Good writing and communication skill required
• Must be able to work independently in a fast-paced multidisciplinary environment, with diverse group of people
• Active team player with excellent interpersonal skill
• Advanced computer knowledge (Word, Excel, Access, PowerPoint, etc.)
• Experience in authoring of Safety Data Sheets (SDS) for Asia Pacific countries is a plus
• Able to multi-task and consensus to follow up with administrative duties and/or paperwork

Job Responsibilities

1. Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
2. Be the subject matter expert on medical devices laws and regulations for product registration in company’s regions of interest.
3. Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process.
4. Involve in the process of product testing, clinical verification, data collection and relevant tracking.
5. Submit to agencies scientific special projects on behalf of the company.
6. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
8. Any other ad-hoc duties or projects as required by the management team.

Job Qualifications:

1. A bachelor's degree in Life Sciences, Pharmacy, Biotechnology or a related field
2. Systematically project management, good planning, execution and timely communication. Good presentation skills.
3. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
4. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for three consecutive years (2021, 2022, 2023).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

A Therapy Area Specialist role, an in-field marketing role, excels in disease and brand knowledge to enable in-depth discussion with healthcare professionals (HCP specialist for example Oncologists, Surgeons) and supports therapy area strategy development & execution in close collaboration with oncology cross-functional team

WHAT YOU WILL DO (it is included but not limited as below mentioned):

Customer Engagement

• Demonstrate in-depth disease, treatment, indication and brand knowledge (including patient pathway, stakeholder mapping) to enable impactful discussion with customers on demand, ensuring service standard are met based on HQ guideline
• Communicate the latest scientific updates within label for both company and competitor products with customers to enable them to make informed decisions about treatment choices
• Facilitate speaker programs; organizes local physician groups for peer-to-peer product education and clinical experience with HCPs
• Provide education to other healthcare stakeholders (e.g. nurses)
• Collaborate closely with cross-functional teams in customer engagement to ensure customer’s scientific needs are addressed timely
• Provide in depth discussion and maintain high engagement level with a list of HCPs under his/her responsibility.

Marketing execution and strategy support

• Document and provide customer insights to cross-functional teams and contribute to key decision maker identification & mapping and brand strategy development
• Develop promotional material development leveraging customer insights gained through customer interactions
• Create contents for local and international conferences, forums, speaker programs etc. (on-label information only)
• Support marketing tactic planning and execution in alignment with brand strategy (event planning, etc.)

Other internal support

• Provide regular internal disease, treatment, indication training to cross-functional team and onboard new customer facing members
• Provide post scientific conference update and training to internal team members for in market indications.
• Contribute to development & execution of account plans in collaboration with cross functional team to deliver impactful strategies that accelerate value for company

WHAT YOU MUST HAVE

• University pharmacy degree or an advanced degree in Life science
• 4 or more years' experience working with HCPs, ideally representing multiple products and working across a complex healthcare system environment
• Good understanding of healthcare environment trends
• Understanding of industry legal, regulatory and compliance landscape
• Ability to assimilate and communicate complex clinical and product information to broad audience of different level of technical expertise
• Experience in building long term customer relationships and advocacy development
• Ability to coach, train, and mentor customer facing team
• Ability to seek out relevant information, prioritize, and apply information to solve complex problems in the ecosystem in a timely manner
• Ability to work in a cross-functional environment and able to collaborate with other team members to provide best support to customers

WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in Pharmaceutical Manufacturing.
• A state-of-the-art facility that delivers solution to its customers world-wide
• Highly engaging team that aims to innovate the future
• Chance to work above site functions, project management exposure and be part of continuous project improvement plan.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Executive Assistant, Medical Affairs

Salary range: $2,300 - 3000

Roles and Responsibilities:

· Serve as primary coverage for educational contact person for the postgraduate programme.

· Assist and support the administration of Postgraduate Training Programmes.

· Assist and support the administration of medical seminars and workshops.

· Plan and administer programme onboarding, and orientation.

· Track all evaluations, monitor, and document compliance.

· Maintain documentation of all training records.

To apply:
Email your resume to:

Salary: up to $2700

Working Days & Hours: Mon-Fri Office Hours

Location: Novena

Job Scope:

• Serve as primary coverage for educational contact person for the postgraduate programme.
• Assist and support the administration of Postgraduate Training Programmes.
• Assist and support the administration of medical seminars and workshops.
• Plan and administer programme onboarding, and orientation.
• Track all evaluations, monitor, and document compliance.
• Maintain documentation of all training records.

Job Requirements:

• Min Diploma in any relevant field preferably in healthcare

For interested applicants, please send your updated resume to: [email protected]
All candidates’ information will be treated with the strictest confidence
Melissa Zhang Zhiqi (Mezzo)
R2197564
Recruit Express Pte Ltd
99C4599

ABOUT THE NATIONAL INSTITUTE OF EDUCATION (NIE)

The National Institute of Education (NIE), Singapore, is Singapore’s national teacher education institute and we are proud to be an integral part of the nation’s education service. We play a key role in the preparation of teachers and in the provision of teacher professional and school leadership development programmes. We are committed to our vision of being An Institute of Distinction: Leading the Future of Education and our mission to Inspire Learning, Transform Teaching and Advance Research. Read more about NIE here.

The National Institute of Education invites suitable candidates to join the Office of Academic and Faculty Affairs (AFA) as a Manager, AFA. This is a 2-year contract post.

ABOUT THE OFFICE OF ACADEMIC AND FACULTY AFFAIRS (AFA)
The Office of Academic and Faculty Affairs oversees the recruitment as well as the career and leadership development of NIE faculty. Day-to-day operations include the full spectrum of administrative processes for faculty appointment, promotion & tenure, contract renewal, and appraisal of faculty. The Office also manages start-up grants, faculty-related data management systems, and faculty recognition awards. Additionally, the AFA Office works closely with the Academic Departments, Human Resource, and IT departments of NIE to ensure the smooth running of all matters related to faculty processes.

JOB SCOPE
The job of the Manager, AFA, is to work collaboratively with the AFA team to manage and perform administrative processes that come under the purview of the AFA Office. The scope includes:

Responsibilities

Management of Faculty-related Processes

• Oversee administrative and evaluative processes for faculty appointments, promotions & tenure, contract renewals, lecturer promotions, and emplacements, ensuring alignment with NIE and NTU guidelines.
• Review dossiers and documents submitted by faculty to ensure accuracy and adherence to university policies.
• Provide guidance and prompt responses to faculty and administrators on faculty-related matters.
• Identify and implement enhancements to streamline faculty-related operations.

Faculty Engagement, Development, and Special Projects

• Organise professional learning communities and engagement sessions to enhance faculty understanding of NIE policies and guidelines.
• Support the operationalisation of faculty development and talent attraction initiatives.
• Collaborate with the Assistant Director and team to design and administer faculty surveys aimed at improving engagement.
• Assist with the planning and rollout of faculty development strategies and initiatives.
• Conduct research, including literature reviews and environment scans, to support faculty development projects.
• Monitor global trends in faculty engagement and development to align NIE’s practices with international standards.

Faculty-related Data Management Systems

• Manage faculty-related data systems (e.g., Student Feedback on Teaching, Academic Workload System, Publications and Research Database System).
• Work with the Digital Solutions Department to troubleshoot technical issues and recommend user-friendly solutions.
• Utilise data analytics to support decision-making and optimise faculty-related processes.

Administrative Support

• Provide secretariat support for meetings, including taking minutes and preparing reports and presentations.
• Draft and maintain advisories, user guides, and standard operating procedures for faculty processes.

Requirements

• A University Degree.
• At least 5 years of relevant experience. Experience in academic administration, HR, or academic publishing in a University setting is advantageous.
• Proficiency in Microsoft Office applications, especially Excel.
• Strong writing, analytical, and organisational skills.
• Exceptional attention to detail, time management, and interpersonal abilities.
• Capacity to manage multiple tasks and interact effectively with stakeholders at different levels.
• Self-motivated, proactive, and resilient.
• Familiarity with digital tools and an ability to leverage technology for process optimisation.

Application

We regret that only shortlisted candidates will be notified.

Other Information

NIE staff can take chartered buses at their own expense from or near their homes to the NIE campus. This is subject to the availability of seats.

• Location: West
• Faculty Development: Manage faculty development initiatives and track performance with the Associate Chair (Faculty).
• Faculty Recruitment: Oversee tenure-track and tenured faculty recruitment, planning outreach and candidate identification.
• Faculty Appointments: Manage non-tenure track faculty appointments and re-appointments, handling the entire process.
• Performance Appraisal: Coordinate and oversee the annual faculty performance appraisal, ensuring timely completion and policy adherence.
• Promotion & Tenure: Lead and manage the faculty promotion and tenure process, ensuring compliance with policies.
• Fellowship Recruitment: Oversee the Fellowship recruitment process.
• Award Nominations: Assist in nominating faculty for local and international awards in collaboration with the Associate Chair and School Chair.
• LinkedIn Recruitment: Manage LinkedIn Recruiter platform to source candidates for faculty and research staff positions.
• Secretariat Role: Serve as the secretariat for major school meetings and discussions.

Interested applicants may email resume to [email protected]

Jessie Hoe Huey Miin (CEI Registration No: R1103861)

Recruit Express Pte Ltd (EA: 99C4599)

• Regulatory Affairs Associate with global Medical Device MNC
• Opportunity to work on local and regional submissions

Partnering with a global Medical Device MNC with an established branding, our client is seeking a Regulatory Affairs & Quality Assurance Executive (6-Months Contract).

Reporting to the RA/QA Director, we are looking for someone with good knowledge of regulatory framework.

In this role, you shall assist in the execution of the regulatory strategies in assigned markets throughout the company product life cycle, with a focus on efficient pre-market and post- market regulatory approvals.

You will also support the review and approval of:

• Change control activities
• Product promotional activities
• Product registration
• Product labeling
• Regulatory inspections and audits

You should have at least 2 years’ of regulatory experience in medical devices and a related science degree.

For more information, please apply with your updated CV (in Word document).

Ambrose Chan

Registration Number: R1218177
EA License Number: 17C8502

Summary of Job Role

The Associate to support our Chief Legal Officer & Company Secretary include ensuring timely service delivery, conducting research, drafting letters, typing and proofreading contracts and documents, preparing Excel lists, assisting in the preparation of Board and committee meetings, drafting minutes, managing the filing system, and ensuring the successful execution of meetings.

Key Responsibilities

1. Assist to check through non-Disclosure agreements and other documents to ensure that they have been properly executed.
2. Draft Board resolutions.
3. Assist in preparation of Board, Board Committee meetings, General meetings and their respective papers.
4. Take and prepare minutes of meetings (if requested)
5. Do research
6. Prepare PowerPoint presentations.
7. Prepare and maintain proper records of the department, the Company and its subsidiaries.
8. Make lodgements with the authorities.
9. Provide administrative, filing, and secretarial support to the department.
10. Arrange meetings and liaise with third parties.
11. Maintain confidentiality on all matters.
12. Such other duties as may be required from time to time.

Job Requirement

1. GCE “O” Levels and above
2. Preferred 2 years or more of working experience
3. Experience at law firms or listed companies or similar secretarial experience is advantageous.
4. Proficient in Microsoft Word, Excel and PowerPoint.

Job Scope:

· Is agile and up to date on regulation changes and assesses their impact on the EPD business and products.

· Monitors and disseminates information on changes related to HSA and APAC (laws & regulations affecting registration, manufacture, and distribution) to regional/global RA and the commercial team.

· Develops and provides registration strategies with its timeline, way to accelerate, anticipate potential risks with mitigation plan of assigned products/projects handling complicated issues, seeking guidance where appropriate.

· Handling new product submissions and product lifecycle management, variations, through authority, and cross-functional engagement to ensure input from cross-functional team members and issues regional regulatory plans as appropriate.

· Prepares and maintains local SOPs and policies relevant to Regulatory Affairs to comply with the company's Global SOPs & policies and local regulation.

· Provides regulatory input and support for marketing plans, product launches, and other cross-functional activities.

· Reviews, and provides input and approval on local promotional materials, product information, packaging, and labels to ensure regulatory compliance.

· Maintains and strengthens good relationships with the Health Sciences Authority of Singapore (HSA).

· Liaises and negotiates with the relevant authorities to facilitate and secure expeditious regulatory approvals.

· Attendance at project teams representing APAC EPD RA of assigned products/projects as appropriate.

· Manage strategy for responding to regulatory agency queries, ensuring scientific dossier content and consistency of scientific content and Company position across APAC.

· Responsible for ensuring the accuracy and quality of documentation.

· Manage the preparation and review of technical strategic regulatory documentation for agency submission.

· Monitor actual vs planned activities and timelines.

· Identify issues impacting project progression and work with the other functions and reporting line to recommend improvements to correct or accelerate project progression

Requirements:

· At least 5 years of regulatory experience in the pharmaceutical industry including OTC, Health supplements, Pharma, and vaccines.

· Required Singapore registered Pharmacist who has access to PRISM (HSA online system).

· Exposure or experience to regional RA is highly preferable.

· Strategic & conceptual thinking, intrapreneurship, prioritization.

· Agility, initiative, integrity, risk-taking, the anticipation of potential issues with mitigation proposal.

· Detailed and able to handle ambiguities.

· Leadership, and collaborative work with cross-functional & cross-level, project management skills.

· Fluent in both verbal and written. Ability to communicate with all levels of management and across different cultural backgrounds.

· Knowledge of local & APAC regulations.

· Well-developed interpersonal, communication, and negotiation skills.

Additional Information:

· Contract duration: 7-9 month, maternity coverage

· Commencement Date: March 2025

· Working days and hours: Mon to Friday, 9am to 6pm

· Location: Duo Tower, Bugis MRT

• Regulatory Affairs Executive with global pharmaceutical company
• Great work culture
• Competitive Remuneration

An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Executive to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.

As the RA Executive, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.

You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is a requirement.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

• Regulatory Affairs Executive with global pharmaceutical company
• Great work culture
• Competitive Remuneration

An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Executive to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.

As the RA Executive, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.

You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is a requirement.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

• Regulatory Affairs Pharmacist with global pharmaceutical company
• Great work culture
• Competitive Remuneration

An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Pharmacist to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.

As the RA Pharmacist, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.

You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is a requirement.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

Key Job Purpose:

• Dossier preparation & product registration submissions to HSA, leading to timely introduction of new products and responsible for supplemental filings for any changes.
• Assisting in data/information gathering & dossier compilation for product registration submission & other related licenses for SAP affiliates & distributors including progress monitoring & follow-ups.
• Provide regulatory support, update, advisory & knowledge sharing to S-Corp, 3rd party manufacturers & other manufacturers and to Sysmex affiliates & distributors in order to remain in compliance with the government regulatory requirements in Asia Pacific.

Job Responsibilities:

1. Product Registration (Local):

• Prepare & submit product registration documentation & other relevant licences’ application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Singapore
• Review and edit dossier to comply with regulatory requirements
• Notify and update Health Sciences Authority (HSA) of any change of particulars / documents related to product registration
• Ensure changes to the approved products are timely submitted to authorities as required
• Ensure and maintain product approvals and licenses, including dealers etc. where applicable
• Manage Adverse Event and Field Safety Corrective Action reporting to HSA within the stipulated timeline
• Maintain product registration record and product registration database in iConnect to ensure proper documentation and record filing
• Maintain registration information in RA modules in S4& GTS and perform regulatory assessment and clearance to order blockage related to regulatory matters.
• Maintain the knowledge and awareness of current applicable regulations and standards and industry guidance in Singapore that impact the company’s compliance
• Support business partners in new product registration, re-registration, renewal and amendment
• Support Sales, Marketing and SCM in all regulatory related areas
• Assisting the operational tasks as required

2. Product Registration (Regional)

• Assisting the AP affiliates & distributors in data/information gathering from manufacturers, drafting/assisting in preparation of initial dossiers for submission
• Maintain product registration records and product registration databases to ensure proper documentation and record filing for all affiliates and business partners countries
• Maintain the knowledge and awareness of current applicable regulations and standards for all affiliates and business partner countries
• Support business partners in new product registration, renewals and amendments
• Support Sales & Marketing and SCM in all regulatory related areas
• Assisting the operational tasks as required

Job Requirements:

• BSc in Medical Science or equivalent
• Min 1 years’ experience in regulatory affairs including regulation research, technical documents creation and regulatory submissions.
• Medical Device Act & other medical device related regulations in Asia Pacific countries
• Fluent in English
• Knowledge of major IVD regulations/standards, at least IVD-R, ISO13485, MDSAP
• Basic computer knowledge & application, e.g. Microsoft Office, Power PDF, etc

• Regulatory Affairs Pharmacist with global pharmaceutical company
• Great work culture
• Competitive Remuneration

An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Pharmacist to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.

As the RA Pharmacist, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.

You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is a requirement.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

• Regulatory Affairs Associate with global Medical Device MNC
• Opportunity to work on local and regional submissions

Partnering with a global Medical Device MNC with an established branding, our client is seeking a Regulatory Affairs & Quality Assurance Executive (6-Months Contract).

Reporting to the RA/QA Director, we are looking for someone with good knowledge of regulatory framework.

In this role, you shall assist in the execution of the regulatory strategies in assigned markets throughout the company product life cycle, with a focus on efficient pre-market and post- market regulatory approvals.

You will also support the review and approval of:

• Change control activities
• Product promotional activities
• Product registration
• Product labeling
• Regulatory inspections and audits

You should have at least 2 years’ of regulatory experience in medical devices and a related science degree.

For more information, please apply with your updated CV (in Word document).

Ambrose Chan

Registration Number: R1218177
EA License Number: 17C8502