Senior Regulatory Affairs Professional

22 hours ago


Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 24,00,000
About Our Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our dynamic organization.

Job Description:

Our team is looking for an experienced professional with sound knowledge in current regulatory standards and practices (US FDA, EU GMP, PIC/s) to fill this role.

  • Compile and review product information to ensure compliance with regulatory requirements.
  • Conduct thorough gap analyses to identify areas of improvement.
  • Handle customer inquiries efficiently and effectively.
  • Manage the entire product life cycle from development to market launch.
  • Ensure accurate documentation of specifications, analytical method validations, development reports, and validation reports.
  • Oversee re-registration procedures and administrative documentations.
  • Maintain validity of registrations and plant GMPs.
Required Skills:
  • Deep understanding of current regulatory standards and practices (US FDA, EU GMP, PIC/s).

This is a challenging yet rewarding role that requires strong technical expertise and excellent communication skills. If you have the necessary qualifications and experience, we encourage you to apply.



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