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Global Regulatory Strategist

2 weeks ago

Rajahmundry, Andhra Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000
Regulatory Compliance Professional

The role entails overseeing the preparation, review, and submission of regulatory documents to global health authorities, ensuring adherence to applicable regulations.

Key Responsibilities:

  • Document Preparation and Submission: Coordinated the preparation, review, and submission of regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Regulatory Compliance: Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Regulatory Interactions: Engaged with regulatory authorities during product submissions, inspections, and audits.
  • Regulatory Strategies: Developed and maintained regulatory strategies to support new product development and lifecycle management.
  • Review and Compliance: Conducted reviews of labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Knowledge Management: 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.
  • Response to Regulatory Queries: Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
  • Documentation and Compliance Records: Managed regulatory documentation archives and maintained compliance records for audits and inspections.