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Senior Regulatory Compliance Officer

3 weeks ago

Udaipur, Rajasthan, India beBeeregulatory Full time ₹ 17,28,000 - ₹ 25,92,000

Job Title: Regulatory Affairs Specialist

We are seeking a seasoned Regulatory Compliance Professional to join our team.

About the Role:

The ideal candidate will possess a deep understanding of regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

  • Main Responsibilities:
  • Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • E nsure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interact with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
  • Develop and maintain regulatory strategies to support new product development and lifecycle management.
  • Review labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Support quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
  • Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  • Assist in responding to regulatory queries, deficiency letters, and inspection findings.
  • Manage regulatory documentation archives and maintain compliance records for audits and inspections.