Required at S Kant HEALTHCARE R&D Center, Turbhe, Navi Mumbai.
Regulatory Associate - Regulatory Affairs
Qualification - B.Pharm / M.Pharm
Experience -3-5 Yrs
Job Responsibility
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 Ministry of Health, International
agencies as well as the various customers.
4. Involved in co-ordination 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 latesh.nemade@skant.com
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