Assistant Manager, Regulatory Affairs
- Location
- India
- Work mode
- On-site
- Employment type
- Full-time
About the job
Regulatory Submissions & Documentation Prepare, review, and submit high‑quality regulatory dossiers (IND/IMPD, BLA/MAA, ANDA/Abbreviated MAA where applicable) for global markets including USFDA, EMA. Ensure accuracy and completeness of CTD/eCTD modules, with strong focus on CMC documentation for biologics/biosimilars. Lead responses to regulatory queries, information requests, and deficiency letters within stipulated timelines.
From Amneal Biosciences's careers page (Oracle Recruiting), checked 29 Oct 2026.
How to apply
- Select Apply on amnealindia.com. It opens Amneal Biosciences's own application form in a new tab, run on Oracle Recruiting.
- Fill in the form and upload your résumé there. Jobiwork never sees your application.
- Amneal Biosciences will reply to you directly. No real employer asks you for money to apply.
Posted 29 Oct 2026 · checked 29 Oct 2026 · Report this job