Regulatory Affairs Jobs at BDR Pharmaceuticals

BDR Group of companies has grown steadily and become a house-hold name in the pharmaceutical Industry over the last 15 years, in both domestic and international arenas. We are recognized as a niche player in manufacturing of Pharmaceutical APIs and for our renowned new age formulations. The group is complemented majorly by its two companies - BDR Pharmaceuticals International Pvt Ltd and BDR Life sciences Pvt. Ltd, each one having stamped its own supremacy in respective fields, i.e. API and formulation manufacturing, respectively.

BDR Pharmaceuticals Internationals Pvt. Ltd Hiring for Regulatory Affairs (API) Department

Department : Regulatory Affairs

Executive / Sr. Executive
Market : ROW, US, EU, Canada, Australia
Experience : • Minimum 4 to 8 years of relevant experience required.
• To have knowledge of ICH guidelines and other regional regulatory requirements
• To compile and Review of Drug Master file as per country- specific regulatory requirements.
• To prepare, review and submit DMF Amendments as per regulatory requirement.
To prepare response to regulatory authority queries

Asst. Manager
Market : ROW, US, EU, Canada, Australia
Experience : • Minimum 8 to 12 years of relevant experience required
• To have knowledge of ICH guidelines and other regional regulatory requirements including USFDA, EMA, NMPA, TGA, CADIFA and other global regulatory market.
• To compile and Review of Drug Master file as per country- specific regulatory requirements.
• To Prepare, review, and submit DMF amendments in accordance with applicable regulatory requirements.
• To Prepare and submit responses to regulatory authority queries within defined timelines.

Job Location : Luna Plant
BDR Pharmaceuticals International Private Limited
R.S. No - 578 & 579, Near Effluent Channel Road, Village : Luna, Tal - Padra, Dist - Vadodara - 391440