Executive, Regulatory Affairs
Amneal Career Sites
Executive, Regulatory Affairs
About this role
- Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
- API DMF and DMF Change Notification review with respect to USFDA regulatory requirement.
- Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects.
- Ability to preliminary review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling
- Drafting of the Annual Report with required submission data as per USFDA guidance.
- Preliminary review of entire submission package.
- Drafting the controlled correspondence/Briefing Package to FDA on specific cases as needed for assigned projects.
- Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames.
- Coordination with Cross Functional teams for the documents availability as per regulatory submission plan.
- Ensure the no delay in drafting and compiling the regulatory submission.
- Maintain regulatory information as per allocated task.
- Having good Regulatory CTD modules drafting & preliminary review skills.
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 Years
Frequently Asked Questions
Is the salary disclosed for the Executive, Regulatory Affairs position at Amneal Career Sites?
The salary for this 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 Executive, Regulatory Affairs position at Amneal Career Sites located?
This 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 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 Executive, Regulatory Affairs role at Amneal Career Sites.
How do I apply for the 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 Executive, Regulatory Affairs job at Amneal Career Sites posted?
This Executive, Regulatory Affairs position at Amneal Career Sites was posted on Aug 26, 2026. Apply as soon as possible — early applications are often reviewed first.
Executive, Regulatory Affairs
Amneal Career Sites
You'll be redirected to Amneal Career Sites's official application page on oraclecloud.