Regulatory Affairs Manager Techcruit Business Solutions

10.0 - 15.0 years

10 - 15 Lacs

hyderabad

Work from Office

Responsibilities: * Exp on procedure of application of new Drug * Manage COPPs, GMP, GLP compliance & SUGAM portal maintenance * Oversee license renewals, dossier reviews & NIB submissions * Trademark License & Coordinate with Drug Control Authority

Posted 3 days ago

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Dy Manager/Manager Talent21

10 - 15 years

8 - 10 Lacs

Hyderabad

Work from Office

Job Description: 1 . Hands on Experience in regulatory submissions preferably for Blood products and Biologics. 2. Review/Submission of applications for new products Manufacturing licenses and renewals. 3. Experience on procedures for application of new drugs (NOC's and Test licenses). 4. Monitoring and ensuring allp certificates (COPPs, GMP, GLP, WHO-GMP and FSC Production Capacity and Performance Certificate) renewals and approvals up to date. 5. Review of Tender certificate. 6. Co-ordinate with Drug control authority personnel for License approvals. 7. Review of Dossiers. 8. Submission of Samples and Documents to NIB, Noida for testing. 9. Updation of the National and international legislation, guidelines and customer practices. 10. Approval of Artworks. 11. Undertake and manage regulatory inspections. 12. Responsible to handle the SUGAM portals and Online Drug licencing system and National single window system (NSWS). 13. Complete knowledge on ROW and EU market registration. 14. Query response submission received from various M. 15. Coordination with the relevant departments for completion of Regulatory works.

Posted 3 months ago

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