Bielefeld: Head of Regulatory Affairs (m/f/d) - Pharma
On-site · Bielefeld, North Rhine-Westphalia, Germany
Job Summary
Head of Regulatory Affairs leading a Regulatory Affairs team (~20 FTE) at a well-established pharma/healthcare company. Define and drive global regulatory strategies across product development, registrations, lifecycle maintenance and market expansion; oversee regulatory lifecycle activities, authority interactions, and compliance; manage product information governance, promotional compliance, and pharmacovigilance systems; act as trusted advisor to executive management; foster cross-functional collaboration with technical, commercial and quality stakeholders; requires extensive leadership experience in regulatory affairs, strong expertise in pharmaceutical regulations, and fluency in German and English. Homeoffice 25% with hybrid model; location: Bielefeld, Germany.
Required Qualifications
- 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
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