Assistant Manager, Regulatory Affairs
AhmedabadFull-time8–12 yrsPosted over a month ago
Leadership pharma role at Hcfa in Ahmedabad. Needs 8–12 years and an M.Pharm.
About the role
Preparation, scientific review, coordination & finalization of ANDA/NDA CMC modules for oral solid, oral liquid, injectable & other dosage form as per the business goals. Preparation of project status, discussion slides & white papers as required for escalation & decision at different stages of the projects.
What you'll do
- Working on due diligence projects for US, EU & Canada markets as per the business agreement
- Managing pre-approval portfolio including original submission, deficiency response, final approval request & any other submissions
- Provide support in developing/updating regulatory tools, checklists, databases as per dept. needs
- Participate in project meetings, communication & coordination with CFTs
What you need
- Regulatory affairs
- Due diligence
- Communication
Good to have
- Technical writing