Regulatory Affairs

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About the Department

In Research & Development, you will be part of a unit that explores bold scientific ideas and advances them into clinical testing. By combining curiosity, AI tools, and human data, the team shapes and delivers an innovative pipeline to meet future patient needs. The Regulatory Affairs team sits at the heart of global development efforts, partnering closely with affiliates, health authorities, and cross-functional colleagues to ensure therapies reach patients efficiently and safely.

Key Responsibilities

• Driving Regulatory Submissions: Lead submission planning, apply regulatory intelligence, and develop strategies. Drive the preparation, maintenance, and submission of global regulatory files (including MAA, NDA/BLA, CTA/IND, Site Master File, renewals, post-approval changes, and commitments), and lead interactions with affiliates.
• Supporting Health Authority Interactions: Contribute to the planning and conduct of regulatory authority interactions. Prepare meeting requests, meeting packages, rehearsals, and minutes from formal meetings, and provide input to affiliates preparing for their own health authority engagements.
• Team Development: Help others grow and build collective capability within the team.

Skills & Qualifications

• Master’s degree with 7+ years of relevant working experience within Regulatory Affairs.
• Solid knowledge of regulatory science and requirements across the EU, US, China, and Japan.
• Proven experience across the drug development lifecycle (early- and late-stage), Life Cycle Management, label development, health authority interactions, device development, and regulatory intelligence.
• Strong understanding of the R&D value chain and broader pharma context, with additional knowledge in CMC, project management, drug-device combination products, quality, clinical pharmacology, or pharmacovigilance.
• Strategic mindset with boldness in decision-making, accountability, persistence, and ability to deliver impactful results.
• Strong communication, mentoring, and team skills with an inclusive mindset and adaptability.
• Fluency in written and spoken English.

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