FDC job vacancy for Regulatory Affairs (US/EU), Regulatory Affairs (ROW) department

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.

WE’RE HIRING

JOIN OUR TEAM

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