Regulatory Affairs Manager

Company Description

NuVvaGen Bioscience (P) Ltd is an export-focused manufacturing company renowned for its advanced automation and state-of-the-art infrastructure. Located near Mumbai (Palghar), the facility spans 100,000 square feet and is equipped with PLC/VFD-enabled machinery to ensure high production efficiency. The plant boasts a Class 100,000 clean room environment and is compliant with GMP certification, adhering to global regulatory standards. NuVvaGen Bioscience delivers premium-quality products to worldwide markets, driven by cutting-edge technology and operational excellence.

Role Description

· Preparation and filing of new drug applications (NDA), abbreviated new drug applications (ANDA) for submission to regulatory authorities.

· Liaise with CDSCO, State FDA, DCGI, and port offices for various regulatory submissions and approvals.

· Handle post-approval changes, renewals, and life-cycle manag...