Sr Manager- Regulatory Affairs EU - Pune

Designation: Senior Manager - Europe Market

Experience: 10-15 Years

Reporting: Head RA

Qualification: B.Pharm/M.Pharm

Job Location: Pune

Team handling experience: 4-6 members

Dosage form: All types

1. Strong experience in Regulatory Affairs for Europe market.

2. To build regulatory strategy for submission of initial MAA for EU (DCP/MRP/NP/CP), evaluation of changes and maintenance of product life-cycle for different dosage forms.

3. Compilation of dossiers in CTD, eCTD & national formats for Europe

4. Compilation and submission of queries and variations.

5. Regulatory compliance with Front offices and with Plant.

6. Review of documents, artworks

7. Review of change controls

8. Gap analysis for new product filing

9. Maintaining product Life cycle

10. Liaise with all cross functional departments for evaluation/approval of change proposal/deviations/escalation and their execution.

11. Internal guidance document preparation.

12. Work allocation to subordinates with tracking and review of tasks.

13. People management- Responsible for training and development of team.

Looking forward for candidates having strong experience in Europe market and capable of leading a team.

If relevant and interested pls share your profile.