
Posted 3 months ago
Bielefeld: Head of Regulatory Affairs (m/f/d) - Pharma
BielefeldOn-site
AI Summary
Head of Regulatory Affairs leads a ~20-person team, defining and driving global regulatory strategies for pharmaceutical products, managing registrations, lifecycle activities, authority interactions, compliance, and pharmacovigilance.
About this role
Our client is a well-established, internationally active healthcare company with a strong footprint in pharmaceutical prescription medicines, OTC products and cosmetics..
As part of continued growth, we are seeking a leader to take responsibility for a broad and strategically important function.
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
Skills
Health Authority InteractionsLifecycle ManagementPharmaceutical RegulationsPharmacovigilanceProduct Information GovernancePromotional ComplianceQPPVRegulatory AffairsRegulatory IntelligenceRegulatory Strategy
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