Strategic Regulatory Affairs Leader, Eastern Europe

POL - 6999 Takeda SCE; Łódź; On-site; PLN 700,000 - 1,000,000; Full time

Job summary

Takeda in Lodz, Poland seeks a Group Head of Regulatory Affairs – Eastern Europe to lead the regional RA organization across LOCs. You will align group and country regulatory strategies with global priorities, supervising RA leaders and ensuring timely registrations, lifecycle management and compliance.

You will collaborate with Medical, Market Access, and Quality to enable patient access, lifecycle planning and successful product launches across the region. English fluency is essential.

Qualifications

• Advanced degree in pharmacy, life/natural sciences, medicine or related discipline.
• Solid expertise in the European regulatory framework (EMA, centralized procedure, MRP/DCP and national procedures).
• 10+ years of regulatory affairs experience in pharma/biopharma, with 5+ years in leadership across multi-country groups.
• Excellent written and spoken English; additional languages are a plus.

Responsibilities

• Provide strategic and operational leadership to the Eastern Europe RA organization.
• Translate European/global RA strategy into a harmonized group regulatory plan.
• Represent the group in regional regulatory strategy forums and portfolio prioritization.
• Build relationships with national authorities and regional bodies.
• Drive harmonization of processes, roles, and quality standards.
• Lead regulatory lifecycle management and ensure compliance across the group.
• Oversee budget and resources; establish governance and KPIs.

Skills

Leadership

Regulatory strategy

Strategic thinking

Stakeholder management

English proficiency

Education

Advanced degree in pharma or life sciences

Regulatory affairs leadership

Leadership training

Job description

Takeda in Lodz, Poland seeks a Group Head of Regulatory Affairs – Eastern Europe to lead the regional RA organization across LOCs. You will align group and country regulatory strategies with global priorities, supervising RA leaders and ensuring timely registrations, lifecycle management and compliance.

You will collaborate with Medical, Market Access, and Quality to enable patient access, lifecycle planning and successful product launches across the region. English fluency is essential.