Deputy Manager, Regulatory Affairs
LifelancerGujarat, India
Posted March 4, 2026
Full Time
About the Company
Amneal is an equal opportunity employer and values diversity and inclusion.
Job Description
The Deputy Manager, Regulatory Affairs will prepare, review, and finalize regulatory strategies for complex products and 505(b)(2) products, draft and review meeting packages, and review API and FP in-vitro characterization/sameness reports.
Requirements
- Suitably qualified individuals with strong Scientific and Regulatory background
- Academic degree in Pharmacy (M. Pharm or PhD), with preferably specialization in Regulatory Affairs or Pharmaceutics
- Experienced (minimum 8-10 years) in Regulatory Affairs with Injectable dosage form and overall experience 12+ years
- End to end complete understanding of Complex Products for US/EU market right from Strategy, Filing, Deficiency response etc.
- Experienced in drafting controlled correspondences, Meeting packages etc.
- Experience being an active contributor to cross-functional teams and/or working in matrix organizations