Regulatory Compliance Specialist

21 hours ago


Aurangabad, Maharashtra, India beBeeCompliance Full time ₹ 11,52,800 - ₹ 23,15,600

Regulatory Affairs Expert Sought

We are looking for an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance.

The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines).

Key Responsibilities:

  • Prepared 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 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.
  • Supported quality systems in alignment with ISO 13485 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 and inspection findings.


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