Regulatory Affairs Manager

Job Title : Senior Regulatory Manager – RoW Market

Department : Regulatory Affairs

Job Summary :

The Senior Regulatory Manager will be responsible for the preparation, review, and submission of high-quality regulatory dossiers and documents for pharmaceutical products intended for Rest of the World (RoW) markets , ensuring compliance with country-specific regulatory requirements. The role involves coordination with internal teams, external partners, and regulatory authorities to ensure timely product approvals and lifecycle management.

Key Responsibilities :

• Thorough knowledge of - Dossier Preparation & Review : 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 : 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 : 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 : Manage regulatory documentation for product variations, renewals, packaging / labelling updates, and post-approval changes.
• Audit & Documentation : Maintain and update regulatory databases and trackers.

Required Qualifications & Experience :

Key Skills :