Regulatory Compliance Specialist

2 days ago

Salem, Tamil Nadu, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Regulatory Compliance Expert

The ideal candidate will have expertise in both pharmaceutical and medical device regulatory compliance.

  • Prepared, reviewed, and submitted regulatory filings, including 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 (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.
  • Assisted in responding to regulatory queries, deficiency letters, and inspection findings.

Benefits:

  • Excellent compensation package.
  • Professional growth opportunities.
  • Collaborative work environment.

Requirements:

  • Regulatory experience in pharmaceuticals and medical devices.
  • Strong analytical and problem-solving skills.
  • Excellent communication and collaboration skills.

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