Deputy Manager, Regulatory Affairs
AhmedabadFull-time12–22 yrsPosted open since may 2026
Leadership pharma role at Hcfa in Ahmedabad. Needs 12+ years and an M.Pharm or PhD.
About the role
Gujarat, India; Ahmedabad City, Gujarat, India Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market. Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market.
What you'll do
- Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes
- Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market
- Draft and finalize controlled correspondences on complex issues
- Draft, Review and Finalize Deficiency responses for Complex Products and 505(b)(2) Products
- Review API and FP in-vitro characterization/sameness reports
What you need
- Regulatory affairs