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