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FDC job vacancy for Regulatory Affairs (US/EU), Regulatory Affairs (ROW), Regulatory Affairs department
FDC carries forward the flaming spirit of it’s first dream, achieving accreditations from the US-FDA, UK-MHRA, MCC-RSA, and the UAE, to cite a few. FDC is a forerunner in the manufacture of ORS and Ophthalmics, by setting up, globally approved, multi-location manufacturing facilities for Active Pharmaceuticals Ingredients (APIs) and Finished Dosage Forms. These facilities are located at Roha, Waluj and Sinnar in Maharashtra, Verna in Goa and Baddi in Himachal Pradesh. FDC has over 300 products and exports the same to over 50 countries, worldwide.
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Department: Regulatory Affairs (US/EU), Regulatory Affairs (ROW), Regulatory Affairs
Offer Designation: Executive/ Senior Executive
Required Experience: 3 to 8 years
Job Description: Preparation of New Applications, Query responses, Post approval changes for EU & US market
Preparation of CTD dossiers country specific format, Quarries responses, Post approval changes for ROW market
New & Renewal applications of drug license, COPP, FSC submissions, WHO-GMP renewal application, Co-ordinate with Local FDA and COSCO for faster approvals and query resolution of on-going application
Job Location: DN Nagar, Andheri (W), Mumbai
Note:
• Those who have relevant experience in above profile only those candidate can apply for this openings.
• Interested candidates, please share your updated CV with the following details:
• Total Number of Experience Current Designation
• Current CTC Expected CTC Notice Period.
Send your updated resume on
pravin.waghole@fdcindia.com
