Manager - Regulatory Affairs

A) Job description: -
1. Review of Original / Updated DMFs / Technical Packages
2. Review response on queries received from outsourced and alternate vendors.
3. To review the supporting documents, declarations, and administrative documents.
4. To review data vis-a-vis existing vendors in case of alternate vendors for APIs
5. To prepare updated API folders / sections for submissions in ANDAs/MAAs etc.
6. To sign off the checklist/ VER along with regulatory comments.
7. To review change notifications.
8. Regulatory Audits of vendors.

B) Relevant work experience - 8 to 12 Years.
 
C) Education Qualification - Post Graduate.