Director Global Regulatory Affairs

Job Title: Director, Global Regulatory Affairs - Europe

Location: Germany | Remote

Employment Type: Full-time, Permanent

We're partnering with a leading global pharmaceutical company to appoint an experienced Director, Global Regulatory Affairs - Europe .

This is a high-profile strategic role supporting global development programmes, with a strong focus on Europe. You'll play a key role in shaping global regulatory strategy, leading interactions with health authorities, and partnering with cross-functional stakeholders to drive successful development, registration, and lifecycle management activities for innovative medicines.

What you'll be doing:

• Develop and execute global regulatory strategies while ensuring European regulatory considerations are effectively integrated into worldwide development programmes
• Lead key regulatory activities across product development and lifecycle management, including MAAs, Scientific Advice, PIPs, Variations, Renewals, and post-approval submissions
• Serve as the primary regulatory interface with the EMA and European competent authorities, leading agency interactions and regulatory meeting preparedness
• Provide strategic regulatory leadership to cross-functional teams across Clinical, Medical, Safety, CMC, Commercial, and other key functions
• Assess regulatory risks and opportunities, influence governance decisions, and drive alignment between regional and global regulatory objectives

What we're looking for:

• 10+ years' experience within Regulatory Affairs in the pharmaceutical or biotechnology industry
• Proven experience developing and driving global regulatory strategy for development-stage and/or marketed products
• Strong European Regulatory Affairs expertise, including direct EMA engagement and health authority interactions
• Experience leading major regulatory submissions, development milestones, and cross-functional regulatory initiatives within global programmes
• Strong understanding of drug development, global regulatory requirements, and the ability to influence stakeholders in complex matrix organisations

Nice to have:

• Experience within biologics, specialty medicines, or other complex products
• Therapeutic area exposure in CNS, Nephrology, Oncology, Immunology, Rare Disease, or other specialty areas
• Previous people management, mentoring, or regulatory leadership experience

Why consider this opportunity?

• Strategic global role with significant influence on regulatory decision‑making across Europe and international development programmes
• Opportunity to work directly with senior global stakeholders and regulatory authorities
• High visibility position supporting innovative products through critical development and registration milestones
• Collaborative, patient-focused culture with strong cross‑functional partnership and knowledge‑sharing
• Leadership opportunity with scope to mentor regulatory professionals and contribute to long‑term organisational growth and success

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