Assistant Manager, Regulatory Affairs
Amneal Career Sites
Assistant Manager, Regulatory Affairs
About this role
Preferred Qualification: M. Pharm.
Preferred Experience: 8-12 yrs (for AM/DM level)
Job Description:
- 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.
- Preparation of project status, discussion slides & white papers as required for escalation & decision at different stages of the projects.
- Assessment of change controls & providing necessary regulatory comments/approval.
- Provide support in developing/updating regulatory tools, checklists, databases as per dept. needs.
- Participate in project meetings, communication & coordination with CFTs.
- Knowledge of relevant regulatory guidelines & updates is must.
- Ability to perform under changing priorities, deadlines & regulatory expectations.
- Skills like, technical writing, presentation, training, effective communication/coordination is preferred.
- Experience of Nitrosamine risk assessment report review will add value.
- A positive learning orientation to quickly adapt Amneal systems, RA tools & processes will add value.
- Knowledge of using AI tools in routine work will add value.
Frequently Asked Questions
Is the salary disclosed for the Assistant Manager, Regulatory Affairs position at Amneal Career Sites?
The salary for this Assistant Manager, Regulatory Affairs role at Amneal Career Sites is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Assistant Manager, Regulatory Affairs position at Amneal Career Sites located?
This Assistant Manager, Regulatory Affairs role at Amneal Career Sites is based in Ahmedabad City, Gujarat, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Assistant Manager, Regulatory Affairs role at Amneal Career Sites full-time or part-time?
This is listed as a Full time position. It is posted as a Assistant Manager, Regulatory Affairs role at Amneal Career Sites.
How do I apply for the Assistant Manager, Regulatory Affairs position at Amneal Career Sites?
Click the "Apply Now" button on this page. You will be redirected to Amneal Career Sites's official application portal hosted on oraclecloud where you can submit your application directly.
When was the Assistant Manager, Regulatory Affairs job at Amneal Career Sites posted?
This Assistant Manager, Regulatory Affairs position at Amneal Career Sites was posted on Sep 11, 2026. Apply as soon as possible — early applications are often reviewed first.
Assistant Manager, Regulatory Affairs
Amneal Career Sites
You'll be redirected to Amneal Career Sites's official application page on oraclecloud.