Senior Regulatory Affairs Executive

3 - 8 years

4 - 7 Lacs

Posted:3 days ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Regulatory & Licensing

  • Prepare and manage applications for WHO certification, manufacturing & wholesale licenses, renewals, FOSCOS, FDA, and other statutory approvals.
  • Handle CBN export NOCs, biodiversity returns, and related compliance filings.
  • Coordinate with FDA officials (domestic & overseas) during licensing, audits, and certifications.
  • Maintain compliance with cGMP, pharmacopoeial & non-pharmacopoeial standards, and GS1 barcode implementation.

Documentation & Dossiers

  • Oversee dossier preparation, submission, and re-registrations for international and domestic markets.
  • Prepare documentation for product registrations, government tenders, and patent projects.
  • Review artwork, promotional materials, and agreements for regulatory compliance.
  • Address MOH and client queries on regulatory submissions.

Product & Portfolio Support

  • Coordinate with plants for commercial batch scale-up and product registrations.
  • Support development of new formulations, product finalization, and execution.
  • Assist in veterinary, nutraceutical, and dental projects as well as new client/product portfolio development.

Stakeholder Coordination

  • Liaise with business development teams, clients, and vendors to obtain required documentation (DMF/BA/BE, CDP, etc.).
  • Guide and train junior regulatory staff, ensuring timely and quality submissions.
  • Support client visits and cross-functional projects across departments.

Audit & Compliance

  • Generate audit compliance reports and assist during plant visits and inspections.
  • Ensure timely renewals and adherence to all regulatory requirements.

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