Eastern Europe Regulatory Affairs Leader

Takeda; Zürich; In loco; CHF 213.000 - 292.000; Tempo pieno

Descrizione del lavoro

Takeda is seeking a Group Head, Regulatory Affairs – Eastern Europe to provide strategic and operational leadership across multiple LOCs. You will translate EU/global strategies into group plans and harmonize regulatory voices across affiliates, working closely with business leadership to enable patient access and lifecycle management.

The role requires 10+ years in regulatory affairs with 5+ years leading multi-country teams, and strong experience with EMA procedures and national requirements.

Competenze

• Advanced degree (PhD, PharmD, MD, MSc or equivalent) in pharmacy, life/natural sciences, medicine or related discipline.

Mansioni

• Provide strategic and operational leadership to the Eastern Europe Regulatory Affairs organization (LOC RA Heads/Leads and teams).
• Translate European/global regulatory strategy into a group plan with a harmonized voice across affiliates.
• Represent group in regional regulatory strategy forums and ensure alignment of portfolio prioritization and launch sequencing.
• Partner with Therapeutic Area Units, Commercial and Marketed Products Development for consistency across group.
• Build and maintain relationships with national authorities and industry bodies.
• Drive harmonization of ways of working, processes, and quality standards across the group RA.

Conoscenze

Strategic thinking

Stakeholder management

Leadership

Regulatory knowledge

English proficiency

Formazione

Advanced degree in pharmacy/biomedical field

Descrizione del lavoro

Takeda is seeking a Group Head, Regulatory Affairs – Eastern Europe to provide strategic and operational leadership across multiple LOCs. You will translate EU/global strategies into group plans and harmonize regulatory voices across affiliates, working closely with business leadership to enable patient access and lifecycle management.

The role requires 10+ years in regulatory affairs with 5+ years leading multi-country teams, and strong experience with EMA procedures and national requirements.