Regulatory CMC Lead Slough

Meeveem Limited; Slough; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work model

Global team collaboration

Job summary

UCB is seeking a Global Regulatory Affairs CMC Lead - Early Development to shape overall CMC strategy, author submissions, and guide cross-functional teams. The role focuses initially on biologics, with interactions across Health Authorities to ensure timely approval and lifecycle planning.

Hybrid work includes office presence in hubs and flexible scheduling. Ideal candidates will have 5+ years in Regulatory Affairs CMC, 8–10 years in pharma or regulatory roles, and experience with accelerated

Qualifications

• Bachelor's degree in a relevant field; master's degree or certificate in regulatory affairs preferred.
• At least five years' Regulatory Affairs CMC experience, 8–10 years in pharma, medical devices or regulatory work.
• Experience contributing to CMC regulatory strategy and clinical submission sections, including bios/advanced therapies.
• Knowledge of global development, post-approval requirements and GMP expectations in at least one ICH region.

Responsibilities

• Define and implement global/regional CMC regulatory strategies and submission plans for early-development products.
• Author and coordinate CMC content, including Modules 2 and 3, and responses to Health Authority questions.
• Lead or support CMC interactions and negotiations with Health Authorities.
• Monitor regulatory changes and use data to strengthen lifecycle planning and decision-making.
• Represent Regulatory CMC in project teams and coach colleagues.

Skills

Regulatory CMC

Global development

Submission planning

Regulatory strategy

Cross-functional collaboration

Education

Bachelor's degree

Master's degree in regulatory affairs

Job description

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 [e-mail]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.