Regulatory Affairs Manager

Job Title: Senior Regulatory Manager – RoW Market

Department

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:

• Must have experience handling RoW markets.
• Strong knowledge of CTD/non-CTD formats and regulatory requirements of RoW markets.
• Experience in dealing with distributors/agents for regulatory submissions.

Key Skills:

• In-depth understanding of pharmaceutical regulatory processes.
• Strong documentation and technical writing skills.
• Ability to interpret and apply regulatory guidelines effectively.
• Excellent communication, coordination, and project management skills.
• Proficiency in MS Office and regulatory databases.