Assistant Manager - Global Regulatory Affairs
ApotexMumbai, Maharashtra, India
Posted January 27, 2026
Full Time
About the Company
Apotex is a Canadian-based global health company that improves everyday access to affordable, innovative medicines and health products for millions of people worldwide.
Job Description
Apotex is seeking an Assistant Manager - Global Regulatory Affairs to lead and manage a Regulatory Affairs team based in Mumbai. The successful candidate will be responsible for reviewing, compiling, and submitting post-launch variations and deficiency responses, as well as handling assessment of change control records and maintenance of product documentation and database records.
Requirements
- A Graduate/ Post graduate degree in Chemistry/Pharmacy/Scientific/business discipline or similar
- Minimum 11 years of regulatory affairs experience in US/CAN/EU/AUS-NZ/ROW markets
- Experience in CMC document writing and review
- Minimum 4 years of experience in managing a team
Benefits
- Accommodation for applicants with disabilities as part of its recruitment process
- Welcoming and accessible work environment
