Make your mark for patients
We 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. You will plan and author high-quality submission content, guide cross-functional teams and support interactions with Health Authorities. You are going to connect scientific evidence, regulatory requirements and business priorities so that submissions progress on time and support product development. You will also anticipate risks, respond to regulatory questions and contribute to better digital and regulatory processes.
Who You Will Work With
You will work within Global Regulatory Affairs, CMC & Devices and partner with Global Regulatory Affairs, Patient Supply and patient-focused teams. 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 Do
- You will define and implement global and regional CMC regulatory strategies and submission plans for assigned early-development products.
- You will author and coordinate clear, consistent CMC content, including Modules 2 and 3, responses to Health Authority questions and briefing documents.
- You will manage complex submissions, source-document requirements, timelines, risks and decisions with cross-functional partners.
- You will lead or support CMC interactions and negotiations with Health Authorities, helping teams resolve regulatory issues effectively.
- You are going to monitor regulatory changes and use digital tools and structured data to strengthen decisions and lifecycle planning.
- You will represent Regulatory CMC in project teams, improve processes and coach colleagues in regulatory CMC practices.
Interested? For this role, we are looking for the following education, experience and skills:
- You have a bachelor's degree in a relevant field; a master's degree or university certificate in regulatory affairs is preferred.
- You bring at least five years’ experience in Regulatory Affairs CMC, and 8-10 years of relevant pharmaceutical, medical device or regulatory-authority experience.
- You have successfully contributed to CMC Regulatory strategy and authored sections for clinical trial submissions for biological or advanced therapy medicinal products, including experience with accelerated development. Additional experience in marketing authorisation or post-approval submissions is beneficial.
- You understand global development and post-approval requirements, GMP expectations and regulatory practices in at least one ICH region.
- You can analyse technical data, create clear regulatory narratives, identify gaps early and manage traceable content across submissions.
- You communicate and negotiate clearly, build inclusive cross-functional relationships and remain adaptable when priorities or regulatory expectations change.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
About Us
UCB 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.
Why work with us?
At 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.
At 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.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.