Regional Regulatory Affairs Coordinator

About the role

The Regional Regulatory Affairs Coordinator will support Viatris in delivering high‑quality medicines worldwide by managing registration strategies and ensuring regulatory dossiers meet local requirements across assigned countries.

Key responsibilities

• Manage projects and product‑related registration strategies in assigned countries.
• Serve as the single point of contact for Global Teams such as Global Branded CMC, Regulatory Science and Global Brands.
• Produce and dispatch dossiers (electronic, paper copy, HA portal) according to defined filing plans and local regulations.
• Interpret and apply regulatory requirements of assigned countries to drug development and marketing‑authorisation dossiers.
• Build and maintain relationships with local regulatory agencies, experts and key opinion leaders.
• Ensure transparency and excellence in the execution of regulatory strategies.
• Maintain systems and databases in line with internal SOPs and policies.
• Support execution of regulatory strategies for registration and maintenance of the product portfolio.
• Liaise with global stakeholders to obtain supporting documents needed for registration requirements.
• Review submission packages for consistency and completeness against local requirements.
• Coordinate receipt, distribution and response to regulatory queries, ensuring response targets are met.
• Represent assigned countries in regulatory and project meetings.

Required profile

• Demonstrated experience in regulatory affairs within the pharmaceutical industry.
• Knowledge of regulatory requirements and filing processes in the assigned countries.
• Ability to work cross‑functionally with global and local teams.
• Strong communication skills to convey regulatory timelines and strategies.

Required skills