Compliance Expert

3 days ago

Bhavnagar, Gujarat, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,20,00,000
Job Title: Regulatory Affairs SpecialistPosition Overview:We are seeking a seasoned 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.The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.Key Responsibilities:
  • Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Maintained regulatory compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Collaborated with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) 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, ICH, and FDA QSR standards.
  • Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  • Responded to regulatory queries, deficiency letters, and inspection findings.
  • Managed regulatory documentation archives and maintained compliance records for audits and inspections.

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    Bhavnagar, Gujarat, India beBeeCompliance Full time ₹ 25,00,000 - ₹ 35,00,000

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    Bhavnagar, Gujarat, India beBeeCompliance Full time ₹ 1,43,00,000 - ₹ 1,81,25,000

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    Bhavnagar, Gujarat, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

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