Regulatory Associate – Regulatory Affairs Required at S Kant HEALTHCARE R&D Center, Turbhe, Navi Mumbai.
Job Title: Regulatory Associate – Regulatory Affairs
Qualification: B.Pharm / M.Pharm
Experience: 3-5 Years
1. Preparing, reviewing, and submitting documents for International Agencies such as IMRES, MISSIONPHARMA, MEG, IDA, UNICEF, PFSCM, and WHO-PREQUALIFICATION.
2. Preparing, reviewing, and submitting product dossiers as per CTD (Common Technical Documents), ACTD, PQ, ROW countries as per guidelines.
3. Preparing, reviewing, and submitting renewal documents/renewal dossiers/ variations/responding to queries raised by the Ministry of Health, International agencies as well as various customers.
4. Involved in coordination with Plant, R&D, and QA-QC Department for preparation and receiving & reviewing of technical Documents such as DMF, Stability data, etc., and also arranging for the samples required for submission along with the product dossiers.
5. Artwork rechecking.
6. Tender submissions.
Interested Candidate send Resume on [email protected]