Bielefeld: Head of Regulatory Affairs (m/f/d) - Pharma

Head of Regulatory Affairs (m/f/d) – Location: Bielefeld

Homeoffice: 25 %

Aufgaben

• Lead the Regualtory 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

Qualifikation

• 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
• Strong business acumen, strategic thinking and pragmatic leadership approach

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

CONTACT:

Silvio Di Meglio
089-80913072-1