Senior Executive, Regulatory Affairs
Amneal Career Sites
Senior Executive, Regulatory Affairs
About this role
JD:
Scientific review of external API vendor’s DMFs in context of global ANDA/NDA & resolving any gaps.
Preparation & review of ANDA/NDA Drug Substance Modules for submission to FDA & related activities.
Participation in project meetings, coordination with CFTs, effective communication & coordination.
Supporting Europe & Canada market projects for Drug substance part, as required.
Knowledge of current regulatory guidelines is required.
Experience of complex APIs will add value.
Knowledge of using AI in routine work will add value.
Local candidate is preferred.
Frequently Asked Questions
Is the salary disclosed for the Senior Executive, Regulatory Affairs position at Amneal Career Sites?
The salary for this Senior Executive, 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 Senior Executive, Regulatory Affairs position at Amneal Career Sites located?
This Senior Executive, 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 Senior Executive, 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 Senior Executive, Regulatory Affairs role at Amneal Career Sites.
How do I apply for the Senior Executive, 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 Senior Executive, Regulatory Affairs job at Amneal Career Sites posted?
This Senior Executive, Regulatory Affairs position at Amneal Career Sites was posted on Sep 7, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Executive, Regulatory Affairs
Amneal Career Sites
You'll be redirected to Amneal Career Sites's official application page on oraclecloud.