Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Limited [Glenmark] is an India-based growing pharmaceutical company headquartered at Mumbai [formerly, Bombay]. Incorporated in 1977, the Company is focused on the manufacture and marketing of formulation products and active pharmaceutical ingredients [API] in India as well as globally and enjoys a diversified and growing presence in regulated and developing international markets. Over the past five years, the Company has also catalysed its growth through investment in dedicated research and development including cutting-edge New Chemical Entity [NCE] research.
Job Title:Â Â Â Regulatory Affairs Officer
Salary:Â Â Â 2,00,000 – 4,00,000 P.A.
Job Description:
Key Responsibilities
1. Life cycle management for RoW.
2. Dossiers as per CTD for emerging markets.
3. Renewal filing in Asia, Africa, MENA, Russia, CIS and Latam regions.
4. Variation filing in Asia, Africa, MENA, Russia, CIS and Latam regions.
5. Response to query raised by MOH/respective Country Health Authority .
6. Arranging working standards/Reference standards/samples etc. required for queries or filing dossiers
7. Approving artworks
8. Application of Legal documents for filings in Asia, Africa, MENA, Russia, CIS and Latam.
9. Initiating change control activity- Reg profile evaluation, artworks and FPS evaluation
10. Change Control initiation in SAP as per the changes proposed w.r.t Artworks , Registrations and renewals, Change in FPS etc.
11. Releasing Registration profiles on receiving Re-registrations of products for regular export
12. Follow up with Country RA for arranging documents, WS, Samples, registration profile
13. Evaluation of DMF with respect to query received from respective Country MOH/Country RA and review of DMFs of alternate vendors.
14. Coordinating with stakeholders for approval of change control
15. Coordinating with Site QA/R&D/Sourcing for Documentation for renewal filing/queries/ variation approval
2. Dossiers as per CTD for emerging markets.
3. Renewal filing in Asia, Africa, MENA, Russia, CIS and Latam regions.
4. Variation filing in Asia, Africa, MENA, Russia, CIS and Latam regions.
5. Response to query raised by MOH/respective Country Health Authority .
6. Arranging working standards/Reference standards/samples etc. required for queries or filing dossiers
7. Approving artworks
8. Application of Legal documents for filings in Asia, Africa, MENA, Russia, CIS and Latam.
9. Initiating change control activity- Reg profile evaluation, artworks and FPS evaluation
10. Change Control initiation in SAP as per the changes proposed w.r.t Artworks , Registrations and renewals, Change in FPS etc.
11. Releasing Registration profiles on receiving Re-registrations of products for regular export
12. Follow up with Country RA for arranging documents, WS, Samples, registration profile
13. Evaluation of DMF with respect to query received from respective Country MOH/Country RA and review of DMFs of alternate vendors.
14. Coordinating with stakeholders for approval of change control
15. Coordinating with Site QA/R&D/Sourcing for Documentation for renewal filing/queries/ variation approval
Qualifications:Â
UG:B.Pharma – Pharmacy, B.Sc – Bio-Chemistry, Chemistry
PG:M.Pharma – Pharmacy, MS/M.Sc(Science) – Bio-Chemistry, Chemistry
