Eastern Europe Regulatory Affairs Leader

Takeda; Łódź; On-site; PLN 900,000 - 1,100,000; Full time

Job summary

Takeda is seeking a Group Head of Regulatory Affairs – Eastern Europe to provide strategic and operational leadership across multiple LOCs. You will align regional regulatory priorities with global strategy, build a high-performing RA group, and ensure compliance across EU and non-EU markets.

You will interact with authorities, stakeholders, and cross-functional teams to enable successful launches and lifecycle management.

Qualifications

• 10+ years of progressive Regulatory Affairs experience in pharma/biotech, including Eastern Europe.
• 5+ years of leadership experience managing multi-country or group teams.
• Solid expertise in the European regulatory framework (EMA, centralized, MRP/DCP, national procedures).
• Demonstrated ability to engage with national authorities and influence regulatory strategy.
• Excellent written and spoken English; multiple group languages an advantage.

Responsibilities

• Provide strategic and operational leadership to the Eastern Europe Regulatory Affairs organization.
• Translate strategy into a group regulatory plan with harmonized voice across affiliates.
• Represent the group in regional regulatory strategy forums and portfolio prioritization.
• Ensure consistent regulatory approach across the group with cross-functional partners.
• Build and maintain relationships with national authorities and industry bodies.
• Drive harmonization of ways of working, processes and quality standards.
• Oversee regulatory lifecycle management across the group portfolio.
• Ensure regulatory compliance and audit readiness.
• Partner with Medical Affairs, Market Access, QA, and Supply Chain for launches and lifecycle management.
• Lead regulatory intelligence and translate changes into strategy and risk mitigation.
• Attract and develop regulatory talent; manage budget and resources.
• Establish governance and KPIs for the group RA organization.

Skills

Strategic thinking

Stakeholder management

Leadership

Cross-cultural collaboration

English proficiency

Education

Advanced degree (PhD, PharmD, MD, MSc) in pharmacy/life sciences

Job description

Takeda is seeking a Group Head of Regulatory Affairs – Eastern Europe to provide strategic and operational leadership across multiple LOCs. You will align regional regulatory priorities with global strategy, build a high-performing RA group, and ensure compliance across EU and non-EU markets.

You will interact with authorities, stakeholders, and cross-functional teams to enable successful launches and lifecycle management.