Regulatory Affairs Team Leader (Pharma Registration)

About the role

We are looking for an experienced Regulatory Affairs Team Leader to head the regulatory team responsible for imported pharmaceutical products in Vietnam. The role involves overseeing daily regulatory activities, ensuring compliance with Ministry of Health regulations, and supporting the expansion of the company’s product portfolio.

Key responsibilities

• Lead and manage the Regulatory Affairs team on a day‑to‑day basis.
• Coordinate and submit registration dossiers for imported medicines.
• Ensure all activities comply with Vietnamese Ministry of Health and GMP requirements.
• Maintain accurate drug registration records and manage product lifecycle documentation.
• Liaise with health authorities, external consultants, and internal stakeholders.
• Support portfolio growth by evaluating regulatory implications of new products.

Required profile

• Bachelor’s degree in Pharmacy (or higher); a registered pharmacist certificate is a plus.
• 6‑8 years of regulatory affairs experience in the pharmaceutical industry.
• At least 3 years in a leadership or team‑lead role.
• Extensive experience with imported drug registration.
• Strong knowledge of CTD format, GMP standards, and Vietnamese pharmaceutical regulations.
• Good command of English for communication with international partners.

Required skills

• Regulatory Affairs
• Drug Registration
• Good Manufacturing Practice (GMP)
• Common Technical Document (CTD) preparation
• Product Lifecycle Management
• Pharmacy knowledge

What we offer

• Competitive salary (negotiable)
• Opportunity to lead a growing regulatory team
• Dynamic work environment in a leading pharmaceutical company