Regulatory Affairs Manager

Company Description

Nu Vva Gen  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. Nu Vva Gen  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 management of registered products.

· Respond to regulatory queries and deficiencies from authorities in a timely and compliant manner.

· Coordinate with QA, QC, R&D, Production, and other departments to collate and review technical documents.

· Review and maintain updated Product Information Files, dossiers, site master files (SMFs), and drug master files (DMFs).

· Ensure product labels and artworks comply with D&C Rules, FSSAI (if nutraceuticals), and other applicable standards.

· Keep abreast of regulatory updates, amendments, and circulars from CDSCO and other global regulatory bodies.

· Provide regulatory input in product development stages to ensure smooth approval pathways.

Qualifications

- Strong understanding of Regulatory Compliance and Regulatory Requirements
- Proficiency in Regulatory Affairs and Management of Regulatory Submissions
- Experience in implementing and maintaining Quality Systems
- Exceptional attention to detail and analytical skills
- Ability to handle regulatory documentation and maintain organized records
- Knowledge of global regulatory standards and GMP compliance
- Bachelor’s or Master’s degree in Life Sciences, Nutraceuticals, or a related field
- Prior professional experience in a regulatory affairs role within the pharmaceutical or biotech industry

· Bachelor's / Master’s degree in Chemistry / BE in Chemicals or equivalent

· 5+ years of experience in Regulatory

· Excellent communication and interpersonal skills

· Strong organizational and time management skills

- · Ability to maintain a high level of confidentiality