Jobs in Regulatory Affairs - executive
Jobs in Regulatory Affairs executive - Amanta Healthcare, based in Ahmedabad (Gujarat) is India's one of the most versatile manufacturer and marketer of sterile dosages in Aseptic BFS (Blow - Fill - Seal ) and ISBM (Injection Stretch Blow Moulding ) space with well integrated operations - F & D to full scale manufacturing & capability to develop customized solutions (containers, closures & drug delivery).
The company is having openings in Regulatory affairs department .Interested candidates can check the details below.
Job Description
1.Periodically maintaining and updating of manufacturing licenses, GMP Certificates and Product Permissions .
2.To apply and obtained additional Product Permission, FSC and COPP from FDCA as per requirement.
3.To apply and obtained various Certificates like Marketing and Manufacturing Certificate, Non-Conviction Certificate and Market Standing Certificate for Tender.
4.To apply and follow up with DCGI officials at,Delhi to take Manufacturing license and Product permission for Large Volume Parenteral section.
5.To apply and obtained No Objection Certificate (NOC) from CDSCO for the purpose of export.
6.Regularly interacting with Regulatory Affairs and Marketing department to understand the licensing work of FDA.
7.To get involved in audits of WHO and does necessary communication with officials to obtain approval and renewal in time frame.
8.To grant and obtained approval on revision of Plant Layout of manufacturing facility from FDCA, Gujarat.
9.Taking Technical Person (TP) approval from FDCA for Technical Personal working in Quality Control and Manufacturing section.
10. To complete legalization work done from various Countrys Embassy for export registration purpose as per requirement.
11. Minimum two Years work with RA Liaisoning.
12. Follow up with officials ( CDSCO, FDCA, Circle Office )
13. Production Permission GMP, COPA, WHO, FSC Application Preparation and submission.
Education-
UG:B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Doctorate:Doctorate Not Required
Experience required - 5 to 6 years
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