Regulatory affairs manager

2 weeks ago

Ahmedabad, Gujarat, India Red Envelope Consultants Full time

Key Responsibilities:Dossier Preparation & Review: o Prepare and review CTD/e CTD/non-CTD dossiers for new product registrations, renewals, and variations for Ro W 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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    Ahmedabad, Gujarat, India Frisch Medical Devices PVT LTD Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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    1 week ago

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