Compliance Specialist Med/Pharma

2 days ago

Rajkot, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 9,99,999 - ₹ 19,99,999

Job Title: Regulatory Affairs Specialist

Location: Remote

We are seeking an experienced professional to lead regulatory affairs with expertise in pharmaceutical and medical device compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, ISO 13485, ICH guidelines).

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.

  • 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 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.

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