Expert Pharmaceutical Regulatory Specialist

11 hours ago

Anand, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 12,00,000 - ₹ 16,00,000

Role Overview:

We are seeking a seasoned Regulatory Affairs Expert with expertise in pharmaceutical and medical device regulatory compliance.

The successful 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:
  • Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Ensure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interact with regulatory authorities during product submissions, inspections, and audits.
  • Develop and maintain regulatory strategies to support 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 to ensure organizational compliance.
  • 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.

Our Ideal Candidate: Has a deep understanding of pharmaceutical and medical device regulatory environments and can effectively collaborate with cross-functional teams.

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