Position: Scientific Regulatory Excellence (Regulatory Affairs) Department

No. of Openings: 02

Work Mode: In office (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
Robust 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
Robust 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.

📌 Specialist Regulatory Affairs Us Market Injectable Experience Must Ahmedabad
🏢 Adecco India
📍 Ahmedabad