OUR COMPANY

We, at RegASK www.regask.com are a high growth global RegTech company leveraging technology and global network of experts to revolutionize regulatory intelligence, serving the LifeSciences (MedTech, CROs, Pharma) and FMCG industries (Food, Personal Care).

RegASK team is highly diverse with more than 10 nationalities across 3 continents, entrepreneurial and very agile, enjoying the benefits of working across industries and across the globe. RegASK just completed its series A funding round in December 2022 and is currently recruiting highly motivated talents to expand its team and support its ambitious growth plans.

RegASK is an international, diverse and rewarding place to work. If you are a builder, highly autonomous in your working style, and eager to problem solve, we would love to hear from you.

RegASK is part of Sprim Global Investments portfolio (https://www.sprim.net), a group of 500+ people in 19 offices across 6 continents, finding solutions, discovering and implementing new ideas to deliver better health.

THE POSITION

Title: Head of Regulatory Affairs (Pharma)

RegASK is a digital platform, using artificial intelligence for augmenting regulatory research. Our technology routinely monitors, anticipates and reports updates or changes to relevant regulations, providing instant alerts. Our platform also allows us to zero-in on applicable regulations to identify and analyse any gaps in the compliance of a product.

RegASK is currently looking for a Head of Regulatory Affairs (Pharma) to join Its growing global Regulatory Affairs team. This leader will have oversight on all content generated on the platform and all RA projects and will be responsible for managing client expectations, watching timelines and budgets, and keeping abreast of client needs.

The Head of Regulatory Affairs (Pharma) should have a strong Pharma and life Science Industry background and will be active in delivering regulatory assessments for Pharma and Medical Devices in link with internal and external experts. The company operates for clients worldwide. This Individual needs a solid understanding of Clinical Trials, submissions process and overall Life Science Industry Regulatory environment.

In this role, you will benefit from the mentorship of highly skilled experts and you will be working in a fast-paced environment managing multiple projects at once, which involve stakeholders across the company.

Reporting to: CEO

Key Responsibilities:

Client Satisfaction:

• Manage the team of Regulatory Affairs (Pharma, Medical Devices, Clinical Trials…) and ensure that projects are delivered on time and with the expected quality
• Ensure the customer satisfaction
• Advise clients on regulatory matters as needed
• Meet clients and present the outcomes of the regulatory assessments during teleconference or in face-to-face meetings
• Lead the projects and liaising with experts as to understand the client scope for proper assistance

Content Strategy:

• Support on identifying the client scope/need and propose a methodology to tackle the request
• Liaise with Marketing, Product and Sales teams and feed them with Customers feedback and requests
• Supervise the content on the platform
• Identify internal areas of improvement and propose best practices to the team

Content Delivery:

• Liaise with clients and SMEs and coordinate with the team for content delivery.
• Write parts of projects and participate in strategy and deliverable development.
• Review technical reports, presentations, and other client’s deliverables.
• Manage RA day to day activities
• Understand the technical issues of the project(s) and find solutions to solve problems.

Leadership :

• Coach, Grow and Develop the team to maximize their Engagement, Performance and Potential
• Live the company Culture & Values and drive a positive team culture where team members feel valued, empowered and developed
• Communicate with your team, peers and leaders in a genuine, transparent way, to maximize the flow of information and support effective collaboration

Profile Required:

• Relevant degree in Pharma, Life Sciences, Biotech industry or equivalent
• Min. 15 years experience related to responsibilities including clinical trials regulatory compliance, authoring of regulatory dossier documentation (including eCTD Modules 1 – 5​), regulatory strategy, product classification, pre-submissions/submissions, etc
• Ability to embrace and engage in digital and AI strategy
• Previous experience leading teams and driving projects to meet deadlines and budgets.
• Details oriented and able to handle regulatory information and submissions with high degree of accuracy
• Excellent communication skills and client-facing skills.
• Ability to create effective and lean PowerPoints
• Skilled in human interactions within multicultural teams, including ability to challenge other experts when deemed justified
• Enjoy working for innovative companies in challenging and demanding environment
• Organized, analytical and result-oriented individual who enjoys a fast-paced entrepreneurial environment
• Ability to plan multiple priorities concurrently

Preferred experience:

• An advanced degree in science and/or Regulatory Affairs.
• Experience with decentralized clinical trials (DCT)
• Experience with Medical Devices submissions.
• Consulting experience in Regulatory Affairs Industry and/or with Regulatory Authorities
• Broad experience across a variety of therapeutic areas.
• Global experience (APAC, Europe, US and/or LATAM projects)

Roles and Responsibility

• Delivery and presentation of lesson content to children
• Supervision primary school children (primary 1 to 6) to ensure completion of daily homework
• Ensure safety and timely transfer of students from school to student centre
• Ensure safety of children
• Regular liaison with parents and guardians regarding children’s progress and behaviour
• Fetching of students from nearby schools
• Administrative work (sales, collection of fees, and collection of forms) and upkeep of centre premises.
• Any other ad-hoc duties as delegated by Centre Head

Requirements:

• Enjoy teaching and passion for kids
• Able to guide primary school subjects.
• Possess excellent work ethics and integrity
• Exhibit a positive attitude when faced with challenges
• Possess a passion for nurturing children, Love children and the learning process
• Have experience in teaching children, preferably at primary level
• Experience in working with children preferred. Those without experience may also apply as training will be provided.
• Able to communicate effectively in both English and Mandarin speaking clients.
• Only Singapore-based need to apply.

Benefits & Highlights:

• Work Style: Hybrid/Flex
• Location: Buona Vista
• Great employee benefit
• Weekly office lunches
• Reporting Line: Regulatory Manager, APAC

About the Role :-

This role will advance Regulatory Affairs (RA) functions by planning and driving initiatives focused on continuous improvements and operational excellence of regulatory systems and processes, as well as creating and maintaining mechanisms for rapid tactical execution of regulatory tasks. With a strong focus on Regulatory Information Management and Analysis, playing a key role in aligning processes and facilitating the effective execution of regulatory related activities; helping to ensure the right level of cross-functional transparency and accountability through the regulatory process.

• Supporting, and at times, driving the initiative for the effective implementation of a Global Regulatory Information Management System (RIMS) within APAC to facilitate the centralisation of common documentation in support of global registration activities and processes.
• Supporting business needs by liaising with internal partners, Regulatory team, IT, and vendors to identify technical solutions and for translating RA processes into executable workflows
• Maintaining traceability from RA information through the decision-making process into materialised outputs
• Anticipating regulatory or related obstacles and emerging issues throughout the product lifecycle, leveraging and developing a mechanism for regular review and associated actions
• In accordance with evolving regulatory requirements and trends, participating, and at times, driving system and process improvement projects, including but not limited to new regulatory policies, processes and SOPs, ensuring appropriate collaboration with stakeholders.

Education and Experience:

• Degree qualified preferably in a Science or Engineering discipline.
• Training in technical operational aspects of Regulatory Affairs, with at least 3 years of direct Regulatory Affairs experience within a medical device company preferably with Orthopaedics
• Able to work independently as well as part of a cross-functional team, with exceptional written and oral communication skills and the ability to successfully build effective working relationship.
• Regulatory Affairs Certification (RAC) an added bonus
• Ability to read and comprehend scientific literature to collect data, establish facts, draw valid conclusions and produce scientifically supported documentation.
• Experience with MS Office as well as SAP

About Arthrex

Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.

Job Description

• Constantly keep abreast of the latest market trends, provide creative, aesthetic and practical recommendations for program production.
• Engage production units to understand resource requirements, plan and map out the resources in consideration of constraints in resources, and ensure success of all productions.
• Guiding the image stylist team to achieve a specific look/effect as required by the production team. Able to provide creative advice and offer alternative solutions.
• Guiding the team towards common goals and come up with procedures / SOPs for better efficiency and productive, stay compliant with financial process and various documentations.
• Ensure proper housekeeping and cataloguing of items to support smooth productions and continuity of productions.
• Oversee the team members in securing sponsors, liaison with suppliers on the costumes & accessories, adhering to the SOP and compliance on the purchases.

Qualifications

• Diploma/Degree in Fashion Design /Merchandising.
• At least 12 Years of relevant work experience, of which 2 years must be in a Supervisory role.
• Possess in-depth working knowledge of Image, Costume, Makeup, Hairstyle.

Benefits & Highlights:

• Work Style: Hybrid/Flex
• Location: Buona Vista
• Great employee benefit
• Weekly office lunches
• Reporting Line: Regulatory Manager, APAC

About the Role :-

Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements. Staying abreast with regulatory compliance requirements and changes affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions.

• Writing, preparing, submitting regulatory documents for the South-East Asia (SEA) market (Arthrex distributor and subsidiary)
• Prioritising and organising multiples projects with competing priorities
• Participating in regulatory affairs planning for SEA markets
• Providing support in APAC level projects as and when needed
• Regularly maintaining and updating product registration and listing databases for the assigned country
• Implementing change control for already-approved products including regulatory submissions
• Keeping abreast with the latest regulatory updates within SEA relating to Arthrex products and ensuring Arthrex as a company is aware, ready and able to comply with the necessary changes
• Providing input to change management projects for global regulatory change assessments
• Participating and providing support in cross-functional collaboration on new product and country launches
• Assisting in activities relating to post market surveillance (i.e. Complaints, Performance Evaluation Reporting (PER), Adverse Event Reporting (AER), and/or liaising with Regulatory bodies in assigned countries)
• Participating in both internal and external quality system audits

Education and Experience:

• Degree qualified preferably in a Science or Engineering discipline
• Minimum 4-5 years direct RA experience within a medical device company
• Strong working knowledge of SEA medical device regulations and standards
• Knowledge of global regulations will be advantageous
• Excellent interpersonal skills, with proven ability to effectively communicate and form strong relationships with stakeholders across all levels
• Ability to work in fast paced environment and handle multiple tasks and requests
• Comprehension of technical, engineering or medical terminology, and/or ability to reference literature for understanding
• Technical skills in manufacturing or design relating to regulatory affairs will be advantageous

About Arthrex

Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.

COMPANY DESCRIPTION

Mediacorp is Singapore’s largest content creator and national media network, operating a suite of TV channels, radio stations, and multiple digital platforms. Its mission is to engage, entertain, and enrich audiences by harnessing the power of creativity.

We are committed to creating an inclusive and diverse workplace where talent thrives. Our hiring decisions are made based on merit and fit-to-role. If you have a disability or special need which requires accommodation to participate in the recruitment process, please inform us when you submit your online application. We will be happy to support as necessary.

Thank you for your interest and application to this role. Please note that only short-listed candidates will be contacted.

RESPONSIBILITIES

Responsibilities:

• The team at TNCA produces content for radio, TV and digital/social platforms.
• As a Senior Producer, you will be responsible for producing and overseeing the content for the radio and TV bulletins.
• Based on your experience, you would handle any of the specific roles on a given day: radio line producer; TV line producer or vetter.
• As a radio line producer, you would copytaste, write and compile the daily radio bulletins. As a TV line producer, you would oversee the production of the daily TV bulletin as well manage the team that produces this.
• As a vetter, you would be vetting the stories written by reporters and producers across all platforms.
• This role requires a seasoned journalist/producer who has a keen news sense and bilingual competency.
• You must uphold and maintain the expected standards pertaining to accuracy, objectivity and timelines.
• You must understand the role of Tamil News within the larger community.
• Connections with key personalities and newsmakers within the Indian/Tamil-speaking community are valuable assets for this position.
• You need to be a team player as your role requires close coordination with your newsroom colleagues as well as colleagues from other departments across Mediacorp.
• You may also be involved in projects and duties assigned by the Chief Editor.

Requirements:

• Good University Degree preferably in Mass Communication or related fields.
• At least 5-7 years of experience in a related field.
• Have a good command of Tamil, both written and spoken for business purpose.
• Have a strong interest in local and international news and current affairs.
• A dynamic individual who is a team player with good communications skill.
• Be prepared to work irregular hours, public holidays and weekends.
• Possess tactful communication and interpersonal skills.
• Be creative and independent.

We are looking for people, who are passionate about education and nurturing young children, to join us!

Positions available: Student Care Teacher

Job Description

• Manage students and proactively respond to their developmental needs
• Ensure classroom discipline and safety of children at all times
• Provide guidance and supervision for Primary School children on the completion of daily homework and spelling
• Plan and prepare enrichment programmes/ activities with other teachers
• update parents regarding children's progress and behaviour

We have centres located islandwide including

• jurong east/west
• woodlands
• yishun
• pasir ris
• tampines
• marine parade
• bedok
• ang mo kio
• toa payoh
• potong pasir
• bukit timah
• upper bukit timah

A level holders waiting for results are welcome!

Job Purpose:

Responsible for planning, developing, delivering and evaluating appropriate individualized educational services, learning programmes and instructions for special needs students in both self-contained and integrated settings in consultation with other school personnel.

Job Responsibilities:

• Implement and monitor effective teaching & learning pedagogies, intervention strategies for students with Special Education Needs (SEN)
• Design and implement valid and reliable modes of assessment to evaluate students’ progress and development.
• Identify and design support structures to students with SEN
• Work with school leaders and management team to plan and implement school-wide educational and recreational programmes
• Collaborate and consult with allied professionals, parents/caregivers and external agencies to ensure quality support and well-being of students
• Responsible for designing, assessing and reviewing student-centric lessons with engaging approaches to accommodate individual learning styles
• Advocate to Heads of Department appropriate instructional learning resources to value add to students’ learning
• Review and reinforce learning activities using lesson plans and teaching strategies to help students to master concepts and skills
• Implement the use of information technology in lesson preparation and teaching to engage learners
• Research and keep abreast of up-to-date subject knowledge and design teaching resources in professional learning teams
• Supervise students and manage pupil behaviours in the classroom and on school premises to inculcate school values and enforce discipline
• Document concerns of students to facilitate problem solving with parents and professional support staff
• Conduct Parent-Teacher Conferencing to discuss students’ strengths, weaknesses and identify areas of focus to support IEP goals and transition
• Provide information to parents for home-school communications to support students’ progress
• Make home visits for students with high support needs and craft intervention strategies to meet student social and emotional needs
• Establish work plan priorities to meet school strategic thrusts
• Actively involved in staff meetings, co-curricular activities, educational conferences, and school programs.
• Participate in parents' evenings and school-wide training events to promote home-school partnership.
• Participate in organizing school events, including sporting events, learning journey and other excursions like camping trips and educational tours

Job Requirements:

• Diploma/ Degree from recognised Institutions with GCE ‘O’ level credits in English and Mathematics
• Prior experience with Students with Mid Intellectual Disabilities (MID) is preferred
• Specific subject knowledge, knowledge in special needs education and behaviour modification, Microsoft office (Excel, Powerpoint, Word)
• Interpersonal skills, classroom management skills, takes Initiative, effective communication Strong in verbal and written English
• Prior experience handling Numeracy/ Literacy, WPLN, Science, HSR, SEL/ CCE and Vocational Guidance is an added advantage.
• Working location: Choa Chu Kang