Regulatory Compliance Expert

3 days ago


Dindigul, Tamil Nadu, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Key Responsibilities of Regulatory Affairs Specialist:

  • Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Ensured compliance with international, federal, and local regulations across pharmaceuticals and medical devices.
  • Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
  • Developed and maintained regulatory strategies to support new product development and lifecycle management.
  • Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
Requirements

We are seeking an experienced professional with expertise in both pharmaceutical and medical device regulatory compliance.

  • Strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration.
  • Ability to maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices.

The ideal candidate will have a strong track record of success in regulatory affairs and be able to demonstrate their expertise in supporting product development, registration, and commercialization.



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