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
Scientific review of external API vendor’s DMFs, preparation & review of ANDA/NDA Drug Substance Modules, and knowledge of current regulatory guidelines required.
Requirements
- Scientific review of external API vendor’s DMFs
- Preparation & review of ANDA/NDA Drug Substance Modules
- Participation in project meetings
- Coordination with CFTs
- Effective communication & coordination
- Supporting Europe & Canada market projects for Drug substance part