Regulatory Affairs Director (EU Lead)

Overview

In this role you will steer EU regulatory strategies to speed oncology innovations from development to lifecycle management. You will lead cross‑functional teams and engage health authorities to secure approvals, shaping labeling and global regulatory plans. Working in a global matrix with scientists, clinicians and commercial teams, you influence strategic decisions that impact patients worldwide. This is a high‑impact opportunity to lead transformative regulatory programs in a world‑class oncology setting.

Pay / Benefits

• global mobility opportunities
• leadership programmes
• career development
• cutting-edge scientific innovation

Responsibilities

• Lead major regulatory submissions (MAA/CTR/IVDR/CTA) and health authority interactions (EMA and national bodies)
• Develop and execute regional/global regulatory strategies to enable rapid approvals and competitive labeling
• Craft EU engagement strategies and briefing documents, and conduct meeting rehearsals and moderations
• Contribute to the Global Regulatory Strategy Team (GRST) and mentor team members
• Deliver regulatory milestones with risk assessment, data considerations, and success probability
• Lead negotiations with health authorities and prepare core regulatory documents
• Plan and assemble global dossiers and core prescribing information, including maintenance and compliance
• Collaborate with marketing and regional regulatory staff to align guidance and perspectives

Key requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Sciences or a related scientific discipline
• +5 years’ experience in regulatory affairs, regulatory strategy, or drug development
• Experience with filing IVDR, CTR, CTAs, MAAs, lifecycle management and oncology regulatory pathways (preferred)
• Strong knowledge of global regulatory affairs across early and late-stage development, especially in Europe
• Excellent communication, strategic thinking and problem-solving skills
• Experience in a global matrix environment and leading cross-functional alignment

• Outstanding communication
• Strategic thinking
• Problem-solving
• Regulatory strategy development
• Health authority interactions (EMA, EU authorities)
• Preparation of briefing documents and labeling strategy

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