Responsibilities
- Lead the Regulatory Affairs team with approx. 20 FTEs
- Define and drive global regulatory strategies across product development, registrations, lifecycle maintenance and market expansion
- Lead regulatory lifecycle activities, authority interactions and compliance risk assessments
- Oversee product information governance, promotional compliance topics and regulatory intelligence
- Ensure effective oversight of vigilance-related systems and associated compliance frameworks
- Manage and develop a larger regulatory department with multiple sub-teams
- Act as trusted advisor to executive management on regulatory strategy and legislative developments
- Foster cross-functional collaboration with technical, commercial and quality stakeholders
- Ensuring and continuously enhancing pharmacovigilance systems in close collaboration with the EU QPPV / local pharmacovigilance function
Requirements
- Scientific degree in Pharmacy, Chemistry, Medicine or related discipline
- Extensive experience in Regulatory Affairs leadership roles
- Strong expertise in pharmaceutical regulations, ideally complemented by broader healthcare product exposure
- Proven track record in organizational leadership and change management
- Experience in global regulatory strategy and health authority interactions
- Fluency in German (C1) and English
Benefits
- Flexible working model with trust-based hours and hybrid working (25% home-office)
- Modern working environment with attractive on-site amenities, including high-quality catering
- Supportive culture with social events, wellbeing initiatives and employee activities
- Family-friendly environment with access to support services and work-life balance offerings
- Strong focus on professional development through trainings, seminars and continuous learning opportunities
- Mobility-related benefits and practical on-site conveniences
Work Arrangement
Hybrid
Team
Team size: 20. Structure: multiple sub-teams
Additional Information
- Fluency in German (C1) and English
