Position: Executive - Regulatory Affairs

Job Location: Ahmedabad, Gujarat

Experience: 1 - 3 years

Salary: Hike on current CTC

Roles:

1. Preparation & Review of Dossiers in ACTD, CTD or Country specific format for ROW market.

2. Preparation and submission of Site GMP Application, Product Registration Applications with respective Regulatory Authorities.

3. Liaoning with Local FDA for Product Permission, FSC, COPP etc. & CDSCO for inclusion of COPP.

4. Coordination with QA/QC departments for technical/legal documents.

5. Artwork designing for registration sample preparation and submission

6. Preparation and/or review of technical documents such as BMR, PVP/PVR, Specification, MOA, COA of raw material, finished product and packing materials and all other documents for compilation of dossiers.

7. Documents preparation for bidding in National & International Tenders

8. MOH query response and resolution within stipulated timeline

DM: southzone@ikamate.com  9974458940