Senior Regulatory Affairs Professional

5 days ago

Kurnool, Andhra Pradesh, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Title: Regulatory Compliance Expert

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Location: Remote

Position Overview:

An experienced professional with expertise in both pharmaceutical and medical device regulatory compliance is sought after to prepare, review, and submit regulatory documentation to global health authorities. The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration.

Key Responsibilities:

  • Prepared, reviewed, and submitted regulatory filings for IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interacted with regulatory authorities 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.
  • Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
  • Managed regulatory documentation archives and maintained compliance records for audits and inspections.

Apply your skills to a challenging role that impacts the entire organization.

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