• 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

Job ID: 19354

• Location: Raffles Place
• Working hours: 8.45m - 5.30pm
• Salary: up to $5,000 (Depending on experiences)

Job Description

• Assist with basic accounting tasks, including recording transactions, preparing simple financial reports, and supporting audits
• Expense-related tasks
• General affairs and administrative support
• Distribution of overseas-related information
• Routine reporting (e.g., daily reports)
• Organizing meetings (preparation of materials, coordination with corporate secretaries, etc.)
• Audit support (coordination with auditors, etc.)
• Operational management

Job Requirement

• Basic knowledge of accounting principles, financial statements, and audits.
• Experience in administrative and secretarial work
• Knowledge and practical experience in expense management, general affairs, and administrative support
• Strong communication and coordination skills, with the ability to work smoothly with other departments and external stakeholders
• High accuracy in administrative tasks and strong time management skills
• Experience in banking or the financial sector is a plus (not required)
• Japanese language skills is required to communicate with Japanese-speaking stakeholders.

Interested applicants, kindly send your updated resume to Joanne (R21101135) [email protected] with the email subject header "Job Application for "19354, General Affairs & Administrative Support".

Only shortlisted candidates will be notified, other applications will be updated to our database for future job opportunities.

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Pasona Singapore Pte Ltd

Joanne Yeo Min Qian
EA License No:90C4069

Registration No.: R21101135

• 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

Job Scope:

• To prepare dossier & product registration submissions for timely introduction of new products and responsible for supplemental filings for any changes.

• To in data/information gathering & dossier compilation for product registration submission & other related licenses for affiliates & distributors including progress monitoring & follow-ups.

• To provide regulatory support, update, advisory & knowledge sharing with, 3rd party manufacturers & other manufacturers and to affiliates & distributors in order to remain in compliance with the government regulatory requirements in Asia Pacific.

Job Requirements:

• BSc in Medical Science or equivalent

• Min 1 years’ experience in regulatory affairs including regulation research, technical documents creation and regulatory submissions.

Interested candidates please send in your resume to:

[email protected]

EA Personnel: Valerie Yong Kian Fung

CEI No.: R1103704

Recruit Express Pte Ltd, EA License No.: 99C4599

General Responsibilities

Local Product Registration

o Prepare and submit product registration documentation and other relevant licences’ application

o Ensure and maintain product approvals and licenses where applicable

o Perform regulatory assessment and clearance to order blockage related to regulatory matters

o Support business partners in new product registration, re-registration, renewal and amendment

o Support Sales, Marketing and regulatory related areas

Regional Product Registration

o Maintain product registration records and databases to ensure proper documentation and record filing

o Maintain the knowledge and awareness of current applicable regulations and standards

o Support business partners in new product registration, renewals and amendments

o Support Sales, Marketing and all regulatory related areas

o 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.

Interested candidates please send in your resume to:

[email protected]

EA Personnel: Valerie Yong Kian Fung

CEI No.: R1103704

Recruit Express Pte Ltd, EA License No.: 99C4599

• 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 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 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 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 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 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

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.

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

• 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 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

Responsibilities

Quality Assurance:

• Overall implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR 820 standards.
• Ensure all departments carry out due processes and documentation required to ensure conformance to the QMS, including design & development, production and software.
• Conduct internal audits and lead external audit preparations.
• Conduct Management Review, onboarding training for new employees, and company-wide refresher training
• Collaborate with cross-functional teams to address non-conformances, CAPAs, and continuous improvement initiatives.
• Participate in risk analysis and management activities to ensure compliance with ISO 14971.
• Support post-market surveillance and vigilance reporting activities.

Regulatory Affairs:

• Preparation, submission, and maintenance of regulatory documentation for market approvals in regions including Singapore, US, Malaysia, and Australia.
• Monitor and interpret regulatory updates and standards relevant to medical devices.
• Ensure labeling, packaging, and promotional materials comply with regulatory requirements.
• Collaborate with the R&D and manufacturing teams to ensure product compliance during development and production phases.
• Maintain accurate and organized records to support regulatory inspections and audits.

Minimum Skills and Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• Ability to work independently and cross-functionally with different teams
• Strong organizational and analytical skills.
• Effective communication and teamwork abilities.

Advantageous Skills

• Knowledge or experience with regulatory submissions to Malaysia MDA, Australia TGA, US FDA, and Singapore HSA.
• Familiarity with ISO 13485, ISO 14971, and other relevant standards.

• 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.

Responsibilities :

• To execute risk management plans for medico-legal cases and clinical complaints to ensure effective resolution for the organization.
• To undertake specific tasks or projects promoting good clinical care in the hospital.
• Manage medico-legal cases and clinical complaints to ensure effective resolution
• Manage claims process and coordinate the renewal and administration of medical malpractice coverage for the organization
• Drive the ML education and communication arm to increase awareness of the latest industry trends and issues
• Serve as a Secretariat to the Clinical Care Review Committee (CCRC)
• Manage ad hoc projects

Requirement :

• Degree in Nursing or equivalent
• Experience in case handling
• Keen to move to a corporate role

If you are interested in the position, do kindly drop your most updated resume to [email protected]

Kailey Lee Jia Yueh

EA Personnel No: R24126040

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

About the role

We are seeking a Temporary Executive (Academic Affairs) to join the National Institute of Early Childhood Development (NIEC) in the West Region on a 7-month contract to cover a maternity leave. In this role, you play a key part in supporting the implementation of academic governance policies and examination-related processes, and providing secretariat support for NIEC Board of Examiners (BOE) meetings.

What you'll be doing

• Issue electronic copy of academic collaterals, print and issue physical copies to NIEC graduates
• Implement academic governance policies and examination-related processes, monitor and rectify any gaps or inconsistencies
• Provide secretariat support for NIEC BOE meetings
• Generate, analyse and exchange data with internal and external stakeholders for planning, reporting and sharing purposes

What we're looking for

• A Bachelor’s degree in any discipline
• Preferably with relevant work experience in Registrar’s Office or Academic Affairs Office
• Knowledge in examination-related processes
• Strong communication and interpersonal skills with the ability to liaise effectively with diverse stakeholders
• Excellent organisational and project management skills with the ability to prioritise and multitask
• IT savvy and proficient in Microsoft Word, Powerpoint and Excel
• High attention to detail, strong analytical, critical thinking and problem-solving skills
• Able to start immediately

• Senior / 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 Senior/ Regulatory Affairs & Quality Assurance Executive.

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.

Candidates with more experience will be considered for a 'Senior Executive' role.

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

Ambrose Chan

Registration Number: R1218177
EA License Number: 17C8502

Responsibilities :

• To execute risk management plans for medico-legal cases and clinical complaints to ensure effective resolution for the organization.
• To undertake specific tasks or projects promoting good clinical care in the hospital.
• Manage medico-legal cases and clinical complaints to ensure effective resolution
• Manage claims process and coordinate the renewal and administration of medical malpractice coverage for the organization
• Drive the ML education and communication arm to increase awareness of the latest industry trends and issues
• Serve as a Secretariat to the Clinical Care Review Committee (CCRC)
• Manage ad hoc projects

Requirement :

• Degree in Nursing or equivalent
• Experience in case handling
• Keen to move to a corporate role

If you are interested in the position, do kindly drop your most updated resume to [email protected]

Kailey Lee Jia Yueh

EA Personnel No: R24126040

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

• Stay updated on regulatory changes and assess their impact on the business and products.
• Communicate updates on HSA and APAC regulations to regional/global RA and commercial teams.
• Develop registration strategies, timelines, and risk mitigation plans for assigned products/projects.
• Manage new product submissions, lifecycle variations, and cross-functional collaboration to meet regulatory requirements.
• Prepare and maintain local SOPs and policies in line with global and local regulations.
• Provide regulatory support for marketing plans, product launches, and promotional material reviews to ensure compliance.
• Maintain strong relationships and negotiate with the Health Sciences Authority (HSA) to secure timely approvals.
• Represent APAC RA in project teams and address regulatory agency queries.
• Ensure accuracy and quality of regulatory documentation and strategic submissions.
• Monitor project progress, identify delays, and recommend improvements to accelerate timelines.

Job Requirements:

• A bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related field
• Minimum of 5 years of regulatory experience in the pharmaceutical industry, covering OTC, health supplements, pharmaceuticals, and vaccines.
• Must be a Singapore-registered Pharmacist with access to PRISM (HSA online system).
• Regional regulatory affairs (RA) experience or exposure is highly desirable.
• Strong strategic and conceptual thinking skills, with an entrepreneurial mindset and the ability to prioritize effectively.
• Demonstrates agility, initiative, integrity, and the ability to anticipate potential issues, coupled with proposing mitigation strategies.
• Meticulous with attention to detail and capable of navigating ambiguities.
• Proven leadership skills and experience working collaboratively across functions, levels, and managing projects.
• Proficiency in English, both spoken and written, with the ability to communicate effectively with all management levels and across diverse cultural backgrounds.
• Comprehensive knowledge of local and APAC regulations.
• Excellent interpersonal, communication, and negotiation abilities.

Location : Bugis

Interested applicants please send your resume to [email protected]

We regret that only short-listed candidates will be notified.

PERSOLKELLY Singapore Pte Ltd EA License No. 01C4394 I RCB No. 200007268E EA Reg. No. R1107631

By sending us your personal data and CV, you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for account creation in GO and the purposes set out in the Privacy Policy https://www.persolkelly.com.sg/policies. You acknowledge that you have read, understood, and agree with GO’s Terms of Use https://go.persolkelly.com/Tac and the Privacy Policy. If you wish to withdraw your consent, please email us at [email protected]. Please feel free to contact us if you have any queries

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 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 & Quality Assurance Executive with Medical Device company
• Opportunity to work on local and regional submissions

Partnering with a leading Medical Device player in its field, our client is seeking a Senior / Regulatory Affairs & Quality Assurance Executive.

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.

Candidates with more experience will be considered for a 'Senior Executive' role.

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

Ambrose Chan

Registration Number: R1218177
EA License Number: 17C8502