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
- leadership
- cross-functional collaboration
- negotiation
- regulatory affairs expertise
- global submission coordination
- licensing and milestone management
Head of Regulatory Affairs Regions (m/f/d) Arbeitgeber: Merz Pharma
Merz Therapeutics ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern nicht nur eine sinnstiftende Tätigkeit im Bereich Datenschutz bietet, sondern auch individuelle Karriereentwicklung in einem wertschätzenden und familiengeführten Umfeld fördert. Mit einem hybriden Arbeitsmodell, attraktiven Sozialleistungen und einem modernen Arbeitsplatz in Frankfurt am Main sorgt das Unternehmen für eine ausgewogene Work-Life-Balance und unterstützt aktiv die persönliche und berufliche Weiterentwicklung seiner Mitarbeiter.
