Regulatory Affairs Manager
Your tasks
Product Registration & Portfolio Lifecycle Management
- Lead end-to-end registration, post-approval variations, license renewals, and withdrawals for a diverse portfolio including General Foods, Health Supplements, OTC Drugs, Generics, and Medical Devices.
- Ensure full compliance of all regulatory dossiers with updated national frameworks and local guidelines.
Authority Engagement & Liaison
- Act as the primary point of contact with key government...
Requirements
Education: Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Food Science, Life Sciences, or a related field. Experience: 5–6 years of hands-on Regulatory Affairs experience spanning food/supplements, pharmaceuticals, or medical devices. Regulatory Expertise:
- Proven expertise in Vietnamese regulatory frameworks.
- Hands-on familiarity with submission portals and procedures under DAV, VFA, NPRA, and MDA.
Key Skills
- Proficiency in written and spoken English and Vietnamese.
- Strong...