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 :

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.