Make your mark for patientsWe are looking for a Global Regulatory Affairs CMC Lead - Early Development who is strategic, collaborative and adaptable to join our Global Regulatory Affairs, CMC & Devices team, based in any of our Brussels (Belgium), Slough (UK), or Raleigh/Atlanta (US) offices.About the role,You will shape and deliver global regulatory CMC strategies for early-development products, with an initial focus on biologics molecules. Working closely with cross functional teams, you will plan and author high-quality regulatory documentation, engage with health authorities, and support timely approvals that meet patient and business needs. You will also anticipate risks, respond to regulatory questions and contribute to better digital and regulatory processes.Who you will work withYou will work within the Global Regulatory Affairs, CMC & Devices team that brings together regulatory, manufacturing, quality, and supply experts from around the world. You will collaborate with regulatory leads, technical experts and colleagues across regions to align strategy,



source documents and submission timelines. You are also going to represent the function in cross-functional discussions, support external regulatory interactions and share your expertise by coaching colleagues.What you will doDefine and deliver integral and regional CMC regulatory strategies and submissions for assigned early-development products.Lead complex regulatory submissions, ensuring consistency, quality, and alignment with agreed global strategies.Author and review clear, consistent CMC content, including Modules 2 and 3, responses to Health Authority questions and briefing documents.Lead or support CMC interactions and negotiations with Health Authorities, helping teams resolve regulatory issues effectively.Anticipate risks across the product lifecycle and communicate solutions clearly to key stakeholders.Monitor regulatory changes and use digital tools and structured data to strengthen decisions and

📌 Regulatory CMC Lead UK (España)
🏢 Ucb Group
📍 España