Regulatory CMC Lead UK

UCB S.A.; Reading; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

UCB is seeking a Global Regulatory Affairs CMC Lead - Early Development to shape global CMC strategies for biologics. The role collaborates across regions to author submissions, respond to health authority questions, and manage lifecycle plans with a hybrid-first work approach.

You will partner with cross-functional teams and coach colleagues while steering regulatory processes in a fast-paced development environment.

Qualifications

• Experience in Regulatory Affairs CMC and strategy development.
• Ability to author regulatory submissions and engage health authorities.
• Strong cross-functional collaboration and risk management.

Responsibilities

• Define and deliver global/regional CMC regulatory strategies and submissions for early-development products.
• Lead complex regulatory submissions with high quality and alignment to global strategies.
• Author and review CMC content including Modules 2 and 3 and health authority responses.
• Lead or support CMC interactions and negotiations with Health Authorities.
• Acknowledge and communicate risks across the product lifecycle to stakeholders.
• Monitor regulatory changes and use digital tools to strengthen decisions and lifecycle planning.
• Support process improvements and coach colleagues within regulatory team.

Skills

Regulatory affairs

CMC expertise

Regulatory strategy

Education

Degree in a relevant field

Job description

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. 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 with

You 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 do

• Define and deliver global 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 lifecycle planning.
• Support process improvement initiatives and coach colleagues within the regulatory team.

Requirements

• A degree in a relevant field, with at least 5 years in Regulatory Affairs CMC and 8-10 years of relevant pharmaceutical, medical device or regulatory-authority experience.
• Proven contribution to CMC regulatory strategy and authorship of clinical trial submission sections for biological or advanced therapy medicinal products, including accelerated development; marketing authorisation or post-approval submission experience is beneficial.
• Experience working with health authorities and supporting regulatory discussions and responses, underpinned by a solid understanding of global development and post-approval requirements, GMP expectations and regulatory practices in at least one ICH region.
• Able to analyse technical data, create clear regulatory narratives, identify gaps early and manage traceable content across submissions.
• Able to communicate and negotiate clearly, build inclusive cross-functional relationships and remain adaptable as priorities or regulatory expectations evolve.
• Demonstrated ability to leverage digital tools, structured data and regulatory information systems to strengthen strategy, submission quality, lifecycle management and decision-making, and to participate in or lead innovation initiatives that drive harmonisation, efficiency and regulatory excellence across global teams.

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 #####.