Regulatory Affairs Executive

2 weeks ago


Vadodara, Gujarat, India RENOWN PHARMACEUTICALS PVT LTD Full time
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy

  • Timely compile materials for license renewals, updates and registrations
  • Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
  • Review labelling and labels for compliance with regulatory requirements
  • Review changes to existing products and SOPs to define the requirements for regulatory submissions
  • Responsible for timely registration of the facility
  • Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
  • Actively participate in evaluation of regulatory compliance of document / product /process /test methods changes
  • Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
  • Salary shall be commensurate to experience and qualification.

Salary:
From ₹15,000.00 per month

Schedule:

  • Day shift

Experience:

- total work: 1 year (preferred)

Ability to Commute:

  • Vadodara, Gujarat (required)

Ability to Relocate:

  • Vadodara, Gujarat: Relocate before starting work (required)

Work Location:
In person

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