Regulatory Compliance Specialist

1 day ago


Erode, Tamil Nadu, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 15,00,000
Job Title: Regulatory Compliance Specialist

Our company seeks a seasoned Regulatory Compliance professional to ensure our products meet global regulatory standards.

Key Responsibilities:

  • Regulatory Documentation: Prepare, review, and submit documentation to health authorities for product submissions.
  • Compliance Management: Ensure compliance with international, federal, and local regulations across pharmaceuticals and medical devices.
  • Authority Liaison: Interact with regulatory authorities (FDA, EMA, CDSCO, MHRA) during product submissions and audits.
  • Regulatory Strategies: Develop strategies to support new product development and lifecycle management.
  • Labeling and Packaging: Review labeling, promotional materials, and product packaging for regulatory compliance.
  • Knowledge Management: Maintain up-to-date knowledge of regulatory changes and industry best practices.
  • Quality Systems: Support quality systems aligned with ISO 13485, ICH, and FDA QSR standards.
  • Cross-Functional Collaboration: Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements.
  • Query Resolution: Assist in responding to regulatory queries and deficiency letters.
  • Documentation Management: Manage regulatory documentation archives and maintain compliance records.

Benefits:

  • A competitive salary and benefits package
  • Opportunities for career growth and professional development
  • A dynamic and supportive work environment

Requirements:

  1. Bachelor's degree in Life Sciences, Pharmacy, or related field
  2. Minimum 5 years of experience in Regulatory Affairs
  3. Strong knowledge of regulatory requirements and industry standards
  4. Excellent communication and project management skills


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