S Kant HEALTHCARE Ltd – Urgently Required for Regulatory Affairs – Apply Now
Required at S Kant HEALTHCARE R&D Center, Turbhe, Navi Mumbai.
Regulatory Associate – Regulatory Affairs
Qualification – B.Pharm / M.Pharm
Experience -3-5 Yrs
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 [email protected]
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube