Head of Regulatory Affairs Regions (m/f/d)

Stellenbeschreibung:

Overview

As Head of Regulatory Affairs Regions, you lead 17 regulatory professionals across two regional teams to ensure timely, compliant regulatory activities throughout the product lifecycle. You drive process optimization, collaborate with affiliates, partners and CROs, and provide regulatory expertise while developing your team. You align regional input with global strategy, manage licensing and milestones, and evaluate regional risks for acquisitions. You shape global submissions and help the organization achieve Better Outcomes for More Patients.

Leistungen / Benefits

career development in a purposeful role
flat hierarchies and open culture
hybrid work model
modern workplaces and company restaurant
WellPass
Deutschland-Ticket (public transport) benefits and JobBike

Verantwortungsbereiche

Lead regional regulatory team, ensure compliance and optimize processes across licenses, budget and organization
Coordinate regional input for global submissions and ensure timely authority responses with global teams
Maintain licenses and provide milestone updates to support global regulatory reporting
Align regional input with global strategy and manage key authority interactions
Assess regional risks and opportunities for product acquisitions
Support departmental goals, collaboration and continuous process improvement

Zentrale Anforderungen

10+ years in regulatory affairs or pharmaceutical industry with clinical, quality and non-clinical exposure
5+ years of line management experience in a global pharmaceutical company leading an international team
Strong knowledge of international regulatory environments and ideally regional experience in 2 regions
Project management and budget control experience
Analytical and strategic mindset with compliance and quality orientation
Solution-oriented team player with good negotiation skills
Excellent English communication; German is a plus