Specialist Regulatory Affairs US Market Injectable experience must

Position: Scientific Regulatory Excellence (Regulatory Affairs) Department

No. of Openings: 02

Work Mode: On-site (No Work from Home)

Working Days: Monday to Saturday (1st & 3rd Saturdays Off)

Experience:

• Injectable and US market experience in Regulatory Affairs
• Strong experience in pre-approval activities for US FDA ANDA filings

Educational Qualification:

• M. Pharm or PhD (Regulatory Affairs / Pharmaceutics preferred)

Key Requirements:

• End-to-end experience in Complex Injectable Products for US market
• Experience in regulatory strategy, ANDA submissions, deficiency responses, controlled correspondences, and meeting packages
• Strong exposure to complex dosage forms such as Peptides, Microspheres, Liposomes, Nano-suspensions, DDCPs, etc.
• Experience in preparation and submission of Pre-ANDA Meeting Packages and Controlled Correspondences
• Experience working with cross-functional teams and development functions
• Strong scientific and regulatory assessment capabilities

Additional Notes:

• Candidates exploring or insisting on Work from Home arrangements should not be considered.
• For outstation candidates, please confirm willingness to relocate to Ahmedabad before sharing the profile.
• We request you to prioritize candidates who do not currently hold competing offers, as offer-based benchmarking often creates challenges during compensation discussions.