Compliance Expert

2 days ago

Chennai, Tamil Nadu, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,20,00,000
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance.

The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations.

Main Responsibilities:

  • 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 regulatory requirements across pharmaceuticals and medical devices.
  • Interacted with regulatory authorities 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 and FDA QSR standards.
  • Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  • Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
  • Managed regulatory documentation archives and maintained compliance records for audits and inspections.

Key Requirements:

  • Strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration.
  • Knowledge of regulatory requirements across pharmaceuticals and medical devices.
  • Ability to interact with regulatory authorities and develop regulatory strategies.
  • Up-to-date knowledge of regulatory changes, guidelines, and industry best practices.

What We Offer:

A competitive compensation package and opportunities for career growth and development in a dynamic and challenging environment.

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