Regulatory CMC Lead UK

UCB S.A.; Princes Risborough; Hybrid; GBP 110,000 - 140,000; Full time

Job summary

UCB S.A. is seeking a Global Regulatory Affairs CMC Lead - Early Development to shape and deliver regulatory CMC strategies for early-stage biologics. You will collaborate with cross-functional teams to author high-quality submissions and engage Health Authorities to drive timely approvals.

You will lead complex submissions, manage risk, and leverage digital tools to improve lifecycle planning while coaching colleagues across regions in a hybrid, global work environment.

Qualifications

• Degree in a relevant field required.
• Proven track record in Regulatory Affairs CMC and submissions.
• Experience with health authorities and global development requirements.
• Ability to analyse technical data and craft regulatory narratives.

Responsibilities

• Define and deliver global/regional CMC strategies and submissions.
• Lead complex regulatory submissions with focus on quality and alignment.
• Author/review Modules 2 and 3 and responses to Health Authority questions.
• Lead or support CMC interactions with Health Authorities and negotiate effectively.
• Anticipate risks and communicate solutions to stakeholders.
• Monitor regulatory changes and leverage digital tools for lifecycle planning.
• Coach colleagues within regulatory teams.

Skills

CMC Regulatory

Regulatory strategy

Health Authority liaison

Regulatory submissions

GMP knowledge

Data/Regulatory systems

Cross-functional leadership

Negotiation

Technical data analysis

Education

Degree in a relevant field

Tools

eCTD tools

RIM (Regulatory Information Management)

Health Authority portals

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 #####.