Galentic Pharma job vacancy for Senior Officer Regulatory Affairs
Since over 25 years, Galentic has been manufacturing and supplying high quality pharmaceutical products. This includes both sterile and non-sterile range. The products are exported to over 40 countries – in the Private Market, Government Organizations and NGOs
Senior Officer Regulatory Affairs
Job Tittle : Regulatory Affairs – Senior Officer
Experience – 4 to 6 years (Pharma industry)
Please find below job description.
1. Co-ordination and follow up with F&D, ADL, Manufacturing, Packing, QC, QA, TT team for getting all the necessary documents as per CTD requirement.
2. Review of all technical data to ensure document compliance and to reduce quality error.
3. Preparation, compilation, review of dossiers within defined time schedules and in accordance with established Standards/Specifications/SOP and Protocols for submission to ROW, ASEAN, AFRICAN countries etc.
4. Dossier compilation for Global Regulatory Authorities: ROW Market, Brazil, CIS Countries & TGA.
5. Queries Response compilation & submission (Queries handling).
6. Provide post-approval compliance by compilation and review of documents (Post-Approval changes).
7. Review of Type II DMF as well as follow-up and review queries related to ODMF.
8. Provide regulatory support and technical assistant to Junior/Sub-ordinate.
9. Preparation, review and compilation of CMC Technical Documents for Internal and External clients for any Quality deviations in product.
10. Helping out to different department to guide for error free document preparation.
11. Update self with regulatory guidelines & if require take training on the same to understand impact on the company quality system.
12. Any other task assigned by Functional Lead and Head of Department.
Interested candidates apply at [email protected]
Job Location – Andheri East, Mumbai (Mumbai based candidates only apply)
