Deputy Manager, Regulatory Affairs

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

• 12–22 yrs of experience
• Regulatory affairs
• M.Pharm or PhD