Executive/Sr. Executive, Regulatory Operations
AmnealAhmedabad, Gujarat, India
Posted April 28, 2026
100000 - 200000 INR
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
Prepare eCTD sequences for ANDAs/NDAs/Amendments/Supplements in alignment with USFDA eCTD technical specifications and ICH guidelines, ensuring accuracy and consistency across summaries and CMC/Quality modules, and perform end-to-end pre-publish checks and validations.
Requirements
- Good knowledge of regulatory guidelines related to eCTD publishing and submissions
- ICH M4, M8, and FDA eCTD guidance knowledge
- Ability to prepare, compile, and publish high-quality eCTD sequences
- Ability to execute precise PDF publishing standards
- Ability to perform end-to-end pre-publish checks and validations
Benefits
- Health Insurance
- Retirement Plan
- Stock Options
- Life Insurance
- Paid Time Off
- Gym Membership
- Employee Assistance Program
- Flexible Work Arrangements