Expert Regulatory Compliance Specialist

2 days ago


Madurai, Tamil Nadu, India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 22,00,000

Regulatory Affairs Expert

We are seeking a seasoned professional to spearhead our regulatory affairs efforts. As a key member of our team, you will be responsible for ensuring compliance with international, federal, and local regulations across pharmaceuticals and medical devices.

  • Key Responsibilities:
  • Develop and implement regulatory strategies to support new product development and lifecycle management.
  • Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Collaborate with cross-functional teams to integrate regulatory requirements into product development.
  • Manage regulatory documentation archives and maintain compliance records for audits and inspections.


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