Assistant Manager, Regulatory Affairs

About the role

Preparation and submission of controlled correspondence Review and compilation of Annual Report with required submission data as per USFDA guidance. Review and compilation of entire supplement/amendment submission package. Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions.

What you'll do

• Review and compilation of Annual Report with required submission data as per USFDA guidance
• Review and compilation of entire supplement/amendment submission package
• Ensure the no delay in drafting and compiling the regulatory submission
• Maintain regulatory information as per allocated task

What you need

• 8–10 yrs of experience
• Regulatory affairs
• B.Pharm or M.Pharm