Regulatory Compliance Expert

1 day ago

Gandhinagar, Gujarat, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Title: Regulatory Affairs Specialist

We are seeking a skilled Regulatory Affairs professional with expertise in pharmaceutical and medical device regulatory compliance. This role involves preparing, reviewing, and submitting regulatory documentation to global health authorities.

  • 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.
About the Role

This position requires an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The successful candidate will be responsible for preparing, reviewing, and submitting regulatory documentation to global health authorities.

The role involves ensuring compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.

Key Responsibilities
  1. Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  2. Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  3. Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
  4. Developed and maintained regulatory strategies to support new product development and lifecycle management.
  5. Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
  6. Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  7. Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
  8. Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  9. Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
  10. Managed regulatory documentation archives and maintained compliance records for audits and inspections.

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