Galentic Pharma (India) Pvt. Ltd – Hiring for Regulatory Affairs

 

Galentic Pharma (India) Pvt. Ltd 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 Organisations and NGOs.

 

Job Title : Executive – Regulatory Affairs

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 our 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.

Job Location – Andheri East, Mumbai

Experience – 4 to 6 years into pharma industry

Apply at career@galentic.in