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 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
• Bachelors or Masters 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 / Masters 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