Regulatory Affairs (RoW)- Asst / Dy Manager

Roles and Responsibilities

1. Preparation, Compilation and Review of dossiers in CTD/country specific format for ASIA or LATAM or AFRICA or MENA & CIS Regions.

2. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities.

3. Manufacturing Site GMP Inspection supports with Customers & Cross Functional Departments.

4. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration.

5. Participating in calls with agents/partners for submission of Dossiers and further updates or requirements if any on product registration.

6. Responding to queries with in the time lines received from client/agency.

7. Preparation of check list as per country specific requirements.

8. Review of documents like Specifications/MFC/BMR/PV/Stability/PDR/DMF/CoAs/Artworks and other quality related documents for their suitability for registration.

9. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration.

10. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base.

11. Identifying gaps in approved dossier compiled and submit the post approval changes (Minor variations) to agent/agency.

12. Filing of variations if any and registration renewals.

13. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments.

14. Maintaining the product status (Registered and under registration) in excel sheet.

Desired Candidate Profile

Need Formulation experience.

Perks and Benefits