S Kant HEALTHCARE Ltd is hiring B. Pharma / M. Pharma candidates with 3-5 years of experience for the position of “Regulatory Associate”.
About S Kant HEALTHCARE Ltd
S Kant Healthcare Ltd. is the formulations division of the SK Group, serving the pharmaceutical industry since 1932. Acquired from M/s. Solvay – Duphar (Holland, EU) in 1996, this mammoth multi-faceted manufacturing facility is spread across 11 acres (Approximately 45,000 sq. meters). Having dedicated buildings for manufacturing of Formulations, APIs, Metallic Stearates, Herbal Extracts, it is truly a World Class Layout in one of India’s largest and finest industrial zones at Vapi, Gujarat. Easily connected by Air, Sea, Road & Rail the geographic location is ideal for serving both domestic and international markets. Having a unilateral flow of man and material through the facility, this EU GMP certified facility has a presence in over 80 countries with the strength of its 400+ employees.
Job Title: Regulatory Associate
Department: Regulatory Affairs
Qualification: B.Pharm / M.Pharm
Work Experience: 3-5 years
Work Location: S Kant HEALTHCARE Ltd. R&D Center, Plot no C-424, Turbhe, M.I.D.C., TTC Industrial Area, Navi Mumbai 400 705, India (View on Google Map)
Job Responsibilities include:
- Preparing, reviewing, and submitting documents for International Agencies such as IMRES, MISSIONPHARMA, MEG, IDA, UNICEF, PFSCM, and WHO-PREQUALIFICATION.
- Preparing, reviewing, and submitting product dossiers as per CTD (Common Technical Documents), ACTD, PQ, ROW countries as per guidelines.
- 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.
- 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.
- Artwork rechecking.
- Tender submissions.