Assistant Manager, Regulatory Affairs
AhmedabadFull-time8–10 yrsPosted over a month ago
Senior pharma role at Hcfa in Ahmedabad. Needs 8–10 years and a B.Pharm or M.Pharm.
About the role
Responsible for managing regulatory affairs activities and regulatory strategy execution to ensure compliance with global regulatory requirements, industry standards, and ethical practices throughout product development and lifecycle management. The role oversees preparation, review, and submission of regulatory dossiers, technical documentation, and product registration applications required for approvals from regulatory authorities.
What you'll do
- Lead and review dossier compilation & publishing for complex submissions
- Oversee DMF compilation & review process and submission strategies
- Direct eCTD & electronic submissions across regions
- Manage post-submission management and health authority responses
- Ensure robust document version control & governance
What you need
- Regulatory affairs
- Documentation