Assistant Manager/Deputy Manager Regulatory Affairs (EU market)

Job description for Regulatory Affairs EU :

1.MAA submission : DCP/NP/MRP/CP submission

2.RUP Submission

3.Life-cyle management

4.MAI application/approval

5.Submissions of variations & renewals

6.Sun-set clause exemption

7.Pharmacovigilance & SDEA activities (RMP, ACOS, PSUR, PSMF, QPPV, xEMPD, Signal management and other PV related activities)

8.Publishing, e-submission, e-validation, CESP gateway

9.Handling of Customer and Agency queries

10. Post approval data management

11. Administrative & CMC activities

12. Review of PDR, BE, Quality documents, agreements

13. Review of Change Control & Artworks

Qualifications and Experience:

• Bachelor / Master Degree in Pharmacy
• Proven experience in ANDA filing & MA submission.
• Strong understanding of regulatory markets.
• Strong leadership and decision-making abilities.
• Demonstrated ability to work in a fast-paced, dynamic environment.