Regulatory Compliance Expert

4 days ago

Mysore, Karnataka, India beBeeRegulatory Full time ₹ 13,00,524 - ₹ 16,40,626

Job Title: Regulatory Compliance Expert

We are seeking an experienced professional to fill the role of Regulatory Compliance Expert.

About the Role:

The successful candidate will have expertise in both pharmaceutical and medical device regulatory compliance. The primary responsibility will be preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations.

Key Responsibilities:

  • Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Ensure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interact with regulatory authorities 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.

Requirements:

  • Extensive experience in pharmaceutical and medical device regulatory compliance.
  • Strong understanding of international, federal, and local regulatory requirements.
  • Excellent communication and interpersonal skills.
  • Able to work effectively in a team environment.
  • Ability to analyze complex information and develop effective solutions.

What We Offer:

  • A competitive compensation package.
  • A dynamic and supportive work environment.

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