Regulatory Affairs Lead – Belarus

About the role

Takeda is seeking a Regulatory Affairs Lead for Belarus to drive national and EAEU regulatory strategy, ensuring product availability and business continuity. The role will oversee product registrations, lifecycle maintenance, and import batch testing to guarantee uninterrupted supply.

Key responsibilities

• Lead the Belarus RA team to meet regulatory timelines and KPIs.
• Develop and execute optimal regulatory strategies for product approvals and lifecycle management.
• Build effective relationships with local commercial teams, distributors, and cross‑functional partners.
• Define and implement Belarus/EAEU registration strategies for medicines, medical devices and related products.
• Manage state registration procedures, renewals and dossier variations in compliance with local legislation.
• Liaise with the EAEU Registration Group to align strategy, timing and dossier content.
• Determine appropriate registration procedures and types for assigned products.
• Prepare and control the regulatory budget, incorporating planned registration activities.
• Ensure timely completion of registration dossiers and adherence to submission deadlines.

Required profile

• Proven experience leading regulatory affairs teams in Belarus or the EAEU region.
• Strong knowledge of national and EAEU registration legislation for medicines and medical devices.
• Demonstrated ability to develop and execute regulatory strategies that accelerate market access.
• Excellent communication and stakeholder‑management skills with health authorities and internal partners.
• Budget planning and project‑management capabilities.

Required skills