Life Sciences Regulatory Affairs Professional

2 days ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Regulatory Compliance Specialist

The ideal candidate will have expertise in both pharmaceutical and medical device regulatory compliance.

  • Key Responsibilities:
  1. Prepare, review, and submit regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines).
  2. Ensure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  3. Interact with regulatory authorities during product submissions, inspections, and audits.
  4. Develop and maintain regulatory strategies to support new product development and lifecycle management.
  5. Review labeling, promotional materials, and product packaging for compliance with applicable regulations.
  6. Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  7. Support quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
  8. Collaborate with cross-functional teams to integrate regulatory requirements into product development.
  9. Assist in responding to regulatory queries, deficiency letters, and inspection findings.
  10. Manage regulatory documentation archives and maintain compliance records for audits and inspections.

The successful candidate will be a detail-oriented individual who can work independently and as part of a team to deliver high-quality results in a fast-paced environment.

This is an opportunity for individuals looking to develop their career in regulatory affairs within the life sciences industry.

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