Executive, Regulatory Affairs
AhmedabadFull-time5–8 yrsPosted over a month ago
Senior pharma role at Hcfa in Ahmedabad. Needs 5–8 years and a B.Pharm or M.Pharm.
About the role
API DMF and DMF Change Notification review with respect to USFDA regulatory requirement. 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.
What you'll do
- Drafting of the Annual Report with required submission data as per USFDA guidance
- Drafting the controlled correspondence/Briefing Package to FDA on specific cases as needed for assigned projects
- Ensure the no delay in drafting and compiling the regulatory submission
- Maintain regulatory information as per allocated task
What you need
- Regulatory affairs