Global Regulatory Compliance Manager

1 day ago


Kolkata, West Bengal, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 22,00,000
Regulatory Affairs ProfessionalWe are seeking a seasoned Regulatory Affairs Specialist with expertise in pharmaceutical and medical device regulatory compliance to join our team.

Key Responsibilities:

  • Prepare, review, and submit regulatory filings for global health authorities.
  • Ensure compliance with international, federal, and local regulations across pharmaceuticals and medical devices.
  • Interact with regulatory authorities during product submissions, inspections, and audits.
  • Develop and maintain regulatory strategies for 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.
  • 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:

  • Strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration.
  • Knowledge of international, federal, and local regulations across pharmaceuticals and medical devices.
  • Ability to interact with regulatory authorities and manage regulatory documentation.
  • Excellent communication and problem-solving skills.


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