Regulatory Affairs Manager
On-site · Bangkok, Bangkok, Thailand
Job Summary
Regulatory Affairs Manager responsible for lifecycle management of pharmaceutical products, including support for change applications (Administrative, Labelling, CMC, Safety), dossier compilation and TOC development, content review of CMC/Labeling documentation and Justification materials, alignment with cross-functional teams on variation procedures and deficiency letters, updating local Product Information and ensuring labeling translation and regulatory compliance of artwork, and overseeing dissemination to authorities. Manage review of Promotional Materials and support regulatory submissions, pharmacovigilance activities (PSUR contributions), regulatory intelligence, and liaison with local Health Authorities as required. The role emphasizes collaboration with Medical Science, publishing, and labeling teams to maintain compliance across markets.
Required Qualifications
- Experience in Regulatory Affairs and lifecycle management of pharmaceutical products
- Ability to support change applications (Administrative, Labelling, CMC, Safety) and submission strategy
- Dossier compilation including preparation of documents (local forms, Cover Letters) and Table of Contents
- Content review of CMC/Labeling documentation/Justification documents
- Alignment with functions on variation procedures, deficiency letters, e.g., CMC, Medical Science, publishing team
- Update/local Product Information (Labelling translation); regulatory compliance of product information/artworks
- Promotional Materials review; familiarity with regulatory guidelines and authorities
- Experience with Safety reporting (PSUR) and regulatory intelligence
- Ability to coordinate with cross-functional teams and contact local Health Authority when required
- Full-time employment
- Global or multinational pharmaceutical experience preferred
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.