Regulatory Affairs jobs in Malaysia
Regulatory Affairs Assistant Manager (Fixed-Term)
TRADER2U SDN. BHD.
Senior Regulatory Affairs Specialist – Regional
Baxter Healthcare
Regulatory Affairs Assistant Manager — Compliance & Strategy
TRADER2U SDN. BHD.
Regional Regulatory Affairs Specialist - Medical Devices
Baxter Healthcare
Group Financial Controller
BIN ZAYED INTERNATIONAL (M) BERHAD
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Gan & Lee Pharmaceuticals
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LIVINGSTONE HEALTHCARE SDN. BHD.
APAC Regulatory Affairs Specialist — Medical Devices
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Gan & Lee Pharmaceuticals
Senior Executive - Regulatory Affairs
LIVINGSTONE HEALTHCARE SDN. BHD.
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Regulatory Affairs Associate
BeOne Medicines
Senior Regulatory Affairs Specialist – Pharma & Medical Devices
TERAJU PHARMA SDN. BHD.
Regulatory Affairs Associate – AU/NZ Trials & Compliance
BeOne Medicines
Strategic Projects Lead: ECF Fundraising & Govt. Liaison
Fuciphagus Agritech Sdn. Bhd.(745875-D) 福喜發铭有限公司
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APAC Michael Page
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Fuciphagus Agritech Sdn. Bhd.(745875-D) 福喜發铭有限公司
Regulatory Affairs Assistant Manager
Job summary
A fast-growing health company in Kuala Lumpur is seeking a Regulatory Affairs Assistant Manager on a fixed-term basis. In this role, you will lead regulatory activities across Asian markets, ensuring compliance with product registrations. The ideal candidate will have at least 5 years of relevant experience, excellent communication skills, and updated knowledge of regional regulatory requirements. We offer competitive remuneration and opportunities for professional development.
Benefits
Qualifications
- At least 5 years of experience in regulatory affairs within healthcare.
- Strong knowledge of product regulatory requirements.
- Excellent written and verbal communication skills.
Responsibilities
- Lead regional regulatory affairs activities and product registration.
- Liaise with authorities and ensure compliance with regulations.
- Manage database of registration requirements and statuses.
Skills
Wellous Group is a fast‑growing health and well‑being company dedicated to delivering innovative, high‑quality products that enhance everyday living. Our focus on research, product development and brand excellence helps us create trusted solutions for healthier lifestyles.
Purpose of the role
Lead regional regulatory affairs activities, including product registration, regulatory compliance, and liaison with authorities across Asian markets, ensuring product licences, certifications and regulatory requirements are properly maintained and updated.
Key Activities
- Act as the point of contact for all Regulatory Affairs (SCR) matters across all regional countries where the group operates.
- Lead, manage and obtain approvals of all product registrations, ensuring compliance with regulations in each Asian region.
- Liaise with the FDA in respective Asian countries on product registration, HS code determination, labelling and related regulatory inquiries.
- Keep abreast of international legislation, guidelines and customer practices.
- Maintain knowledge and development of local food regulatory licences and applications such as HALAL, HACCP and others for the group.
- Participate in continuous improvement activities and propose process enhancements to improve submission efficiency and accuracy.
- Maintain a complete database of registration requirements, status/expiry dates and renewal deadlines for domestic and regional countries.
- Maintain product licence validity and apply for re‑registration when necessary.
- Perform ad‑hoc tasks assigned by the Head of Product Development from time to time.
Job Requirements
- At least 5 years of Science & Regulatory Affairs relevant experience in the healthcare industry.
- Updated knowledge of Asian regional product regulatory requirements a plus.
- Excellent written and verbal communication skills.
What we offer
Our fixed‑term Regulatory Affairs Assistant Manager role offers competitive remuneration, opportunities for professional development and a range of employee benefits to support your well‑being.
If you are excited about this opportunity and believe you have the skills and experience to excel, we encourage you to apply now.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.