M/s. ICHOR Biologics Pvt ltd., situated at Sy.No.222P Thurkapally Village, Shameerpet Mandal, Medchal Malkajgiri Dist – 500078 situated in the Genome Valley area. Is a specialty plasma derived biopharmaceuticals company committed to innovate, develop and commercialize high-quality plasma derivatives to save lives and enhance the quality of life for the people.
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.
How to Apply:
- Male candidates Only
- Send Your “CV” To: Resumes@ichor.in
- 9154313376
