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Amneal Biosciences
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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

  1. Select Apply on amnealindia.com. It opens Amneal Biosciences's own application form in a new tab, run on Oracle Recruiting.
  2. Fill in the form and upload your résumé there. Jobiwork never sees your application.
  3. 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

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