Senior Executive, Regulatory Affairs
AmnealAhmedabad, Gujarat, India
Posted April 28, 2026
Full Time
About the Company
Amneal is a dynamic pharmaceutical company focused on delivering affordable access to essential medicines. With a robust generics business and growing portfolios in injectables, biosimilars, and international markets, Amneal invests in scientific rigor, production capabilities, and employee well-being to enhance its value proposition.
Job Description
Senior Executive, Regulatory Affairs job description. Good knowledge of ANDA submission activities and post-approval procedures. Exposure to various dosage forms and manufacturing processes.
Requirements
- Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
- Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects.
- Ability to preliminary review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance