Senior Director Regulatory Affairs
Discover International
A Senior regulatory leader responsible for EU regulatory strategy and execution across oncology and non-oncology development programmes, acting as the EU/Global Regulatory Lead from early development through approval and lifecycle management. Key Responsibilities Lead EU regulatory strategy and EMA/CHMP engagement, including Scientific Advice. Oversee CTA and MAA submissions, regulatory responses and approval activities. Partner with Clinical, CMC, Safety, Medical and Commercial teams to align regulatory strategy. Identify and mitigate regulatory risks across clinical development, endpoints, CMC, safety and biomarkers. Provide regulatory intelligence and strategic advice to senior leadership. Lead cross-functional regulatory teams and support development of regulatory colleagues. Requirements 12+ years' pharma/biotech Regulatory Affairs experience. Strong EU/EMA regulatory strategy experience across development phases. Proven experience with major submissions and/or approvals. Oncology experience strongly preferred. Experience leading EMA Scientific Advice and/or CHMP interactions. Strong knowledge of EU/ICH regulations and drug development strategy. Excellent stakeholder management, regulatory writing and health authority negotiation skills. Life sciences degree required; advanced degree preferred. #J-18808-Ljbffr
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