Regulatory Affairs Manager

3 days ago

Ahmedabad, Gujarat, India Red Envelope Consultants Full time US$ 80,000 - US$ 1,20,000 per year

Key Responsibilities:

  • Dossier Preparation & Review: o Prepare and review CTD/eCTD/non-CTD dossiers for new product registrations, renewals, and variations for RoW markets (e.g., Africa, Southeast Asia, CIS, LATAM).
  • Ensure dossiers are in line with current regulatory guidelines and client expectations.
  • Regulatory Submissions & Approvals: o Coordinate with agents for regulatory submission and queries.
  • Track and manage timelines for submissions and approvals to ensure compliance with project milestones.
  • Regulatory Intelligence & Compliance: o Monitor changes in regulatory guidelines and keep relevant stakeholders informed.
  • Ensure all submissions and regulatory strategies align with applicable national and international regulations.
  • Lifecycle Management: o Manage regulatory documentation for product variations, renewals, packaging/labelling updates, and post-approval changes.
  • Audit & Documentation: o Maintain and update regulatory databases and trackers.

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