Regulatory Affairs Career

4 days ago

Bareilly, Uttar Pradesh, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 25,00,000

Job Role:

Regulatory Affairs Professional needed for a challenging role in pharmaceutical and medical device regulatory compliance.

Responsibilities will include 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:
  • 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.

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