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Hiring companyAmneal
Verified 3 days ago
Senior Executive, Regulatory Affairs
Ahmedabad City, Gujarat, India Full-time On-site
About the role
Regulatory Affairs team at Amneal ensures product compliance and market access across global regions. The Senior Executive prepares and submits CTD/ACTD dossiers, coordinates regulatory strategy, manages post‑approval changes, and interacts with health authorities. Based in Ahmedabad City, Gujarat, India, on-site work model.
What you’ll do
- Prepare, review, and submit CTD/ACTD dossiers for new products and variations
- Coordinate compilation of dossier modules with QA, QC, R&D, CMC, PV, PM, and Manufacturing
- Ensure dossier compliance with WHO, ICH, and local authority guidelines
- Support business development with regulatory feasibility assessments
- Manage post‑approval changes including CMC variations and labeling updates
- Handle deficiency letters and queries from regulatory agencies
- Monitor regulatory guideline updates for RoW markets
What you’ll bring
- M.Pharm / B.Pharm
- 7-9 years in Pharmaceutical Regulatory Affairs
Nice to have
- M.Pharm / B.Pharm
- 7-9 years in Pharmaceutical Regulatory Affairs
Education
Master of Pharmacy