Ichor Biologics is a pre-clinical biotechnology company based in New York City, specializing in the development of antibody-based therapeutics to combat infectious diseases.
Requirement details:
OPEN POSITION: Regulatory Affairs
Position: Dy. Manager/Manager
Exp: 10-15 year
Job description:
Hand on Experience in regulatory submissions predominantly for Blood products and Biologics companies’ Only.
Review of applications for new products Manufacturing licenses and renewals.
Experience on procedures for application of new drugs (NOC’s and Test licenses).
Monitor of certificates (COPPs, GMP, GLP, WHO-GMP and FSC Production Capacity and Performance Certificate) renewals and approvals up to date. Review of Tender certificate.
Co-ordinate with Drug control authority personnel for License approvals. Review of Dossiers.
Submission of Samples and Documents to NIB, Noida for testing.
Updation of the National and international legislation, guidelines, and customer practices. Approval of Artworks.
Undertake and manage regulatory inspections, Domestic market experience.
Responsible to handle the SUGAM portals and Online Drug licensing system and National single window system (NSWS).
Complete knowledge on ROW and EU market registration.
Query response submission received from various MoH.Experience in Trademark License.
Managing the Team for completion of Regulatory works.
Coordination with Quality and Operation function for framing/availability the document as per the regulatory expectation
Male candidates Only
Apply details:
→ Send Your “CV” To:
[email protected]
9154513376
