Executive, Regulatory Affairs

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

• 5–8 yrs of experience
• Regulatory affairs
• B.Pharm or M.Pharm