Amneal Biosciences
From company careers site
Assistant Manager, Regulatory Affairs
- Location
- Ahmedabad City, Gujarat, India
- Work mode
- On-site
- Employment type
- Full-time
About the job
• Preparation, scientific review, coordination & finalization of ANDA/NDA CMC modules for oral solid, oral liquid, injectable & other dosage form as per the business goals.
- Preparation, scientific review, coordination & finalization of ANDA/NDA CMC modules for oral solid, oral liquid, injectable & other dosage form as per the business goals.
- Working on due diligence projects for US, EU & Canada markets as per the business agreement.
- Managing pre-approval portfolio including original submission, deficiency response, final approval request & any other submissions.
- Assessment of change controls & providing necessary regulatory comments/approval.
- Knowledge of relevant regulatory guidelines & updates is must.
- Skills like, technical writing, presentation, training, effective communication/coordination is preferred.
From Amneal Biosciences's careers page (Oracle Recruiting), checked 27 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 1 Oct 2026 · checked 27 Oct 2026 · Report this job