Global Regulatory Compliance Specialist

1 day ago

Guntur, Andhra Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000

Regulatory Affairs Expert Role

Job Summary:

We are seeking a seasoned Regulatory Affairs professional with in-depth knowledge of pharmaceutical and medical device regulatory compliance.

Key Responsibilities:

  • Develop, review, and submit high-quality regulatory filings to global health authorities, ensuring adherence to applicable regulations.
  • Maintain expert understanding of international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Collaborate with regulatory authorities during product submissions, inspections, and audits.
  • Establish and maintain robust regulatory strategies to support new product development and lifecycle management.
  • Review labeling, promotional materials, and product packaging for compliance with regulatory standards.
  • Stay up-to-date on the latest regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Support quality systems aligned with ISO 13485, ICH, and FDA QSR standards.
  • Partner with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  • Respond to regulatory queries, deficiency letters, and inspection findings.
  • Manage regulatory documentation archives and maintain compliance records for audits and inspections.

Requirements:

  • Proven background in regulatory submissions, product lifecycle management, and cross-functional collaboration.
  • Experience working with regulatory authorities, including FDA, EMA, CDSCO, MHRA, and Notified Bodies.
  • Expertise in ISO 13485, ICH, and FDA QSR standards.
  • Ability to develop and maintain complex regulatory strategies.
  • Excellent communication and problem-solving skills.

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