Ph3Overview /h3pbMake your mark for patients /b. We are looking for a bGlobal Regulatory Affairs CMC Lead /b who is collaborative, strategic, and delivery focused to join us in our bGlobal Regulatory Affairs /b team, based in any of our Brussels (Belgium), Slough (UK) or Atlanta (US) offices. /ph3What You’ll Do /h3ulliDefine and deliver regulatory strategies for global or regional specific CMC submissions for assigned projects/products across development and post approval stages. /liliLead complex regulatory submissions, ensuring consistency, quality, and alignment with agreed global strategies. /liliAuthor and review regulatory CMC documentation within agreed timelines. /liliRepresent regulatory CMC expertise in cross functional project teams and authority interactions, as needed. /liliAnticipate risks across the product lifecycle and communicate solutions clearly to key stakeholders. /liliSupport process improvement initiatives and mentor colleagues within the regulatory team. /li /ulh3Who You’ll Work With /h3pYou will be working in a team that brings together regulatory, manufacturing, quality, and supply experts from around the world. The team collaborates closely with other functions in global regulatory affairs, development, technical and supply teams, creating strong partnerships to support innovative therapies. You will also engage with global stakeholders and external authorities, contributing your expertise across cross-functional projects. /ph3Qualifications /h3ulliA degree in a scientific or technical discipline; advanced or regulatory qualifications are an advantage. /liliExtensive experience in pharmaceutical industry and in regulatory roles, including global submissions and working with health authorities supporting regulatory discussions. /liliExcellence and proven track record of successful regulatory strategic authoring and contribution to delivering regulatory CMC documentation of new marketing authorisations, clinical trial applications and post-approval submissions. /liliExperience working with health authorities and supporting regulatory discussions and responses. /liliDemonstrated ability to leverage digital tools, structured data, and regulatory information systems to enhance regulatory strategy, submission quality, lifecycle management, and decision making across global markets. /liliAbility to participate or lead and embed digital and process innovation initiatives within the team, driving harmonization, efficiency, and regulatory excellence across cross‑functional and global teams. /li /ulh3About Us /h3pUCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9,000 people in all four corners of the globe, inspired by patients and driven by science. /ph3Why work with us? /h3pAt UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. /ppAt UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office. /ppUCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. /ppShould you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel. /p /p #J-18808-Ljbffr