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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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