Get notified of more jobs like this · No spam, ever
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
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
- Define and implement global and regional CMC regulatory strategies and submission plans for assigned early-development products.
- Author and coordinate clear, consistent CMC content, including Modules 2 and 3, responses to Health Authority questions and briefing documents.
- Manage complex submissions, source-document requirements, timelines, risks and decisions with cross-functional partners.
- Lead or support CMC interactions and negotiations with Health Authorities, helping teams resolve regulatory issues effectively.
- Monitor regulatory changes and use digital tools and structured data to strengthen decisions and lifecycle planning.
- Represent Regulatory CMC in project teams, improve processes and coach colleagues in regulatory CMC practices.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
Requirements
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.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
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 EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Location