Senior Pharmaceutical Regulatory Consultant

4 days ago

Mount Abu, Rajasthan, India beBeeRegulatoryAffairs Full time ₹ 20,00,000 - ₹ 25,00,000
Regulatory Affairs Professional

Job Title: Regulatory Affairs Specialist Med/Pharma (Female)

Location: Remote

Position Overview:

We are seeking 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.

Key Responsibilities:

  • Regulatory Filings: Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Compliance: Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Regulatory Interactions: Interacted with regulatory authorities during product submissions, inspections, and audits.
  • Regulatory Strategies: Developed and maintained regulatory strategies to support new product development and lifecycle management.
  • Labeling Compliance: Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Regulatory Knowledge: Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Quality Systems: Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
  • Cross-Functional Collaboration: Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  • Regulatory Queries: Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
  • Document Management: Managed regulatory documentation archives and maintained compliance records for audits and inspections.

This position requires a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

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