Global Regulatory Affairs CMC Lead

UCB • Atlanta, GA

1d • Hybrid

About The Position

We are looking for a Global Regulatory Affairs CMC Lead who is collaborative, strategic, and delivery focused to join us in our Global Regulatory Affairs team, based in any of our Brussels (Belgium), Slough (UK) or Atlanta (US) offices.
About the role
You will lead regulatory strategies, planning and preparation of global or regional specific CMC submissions for assigned projects/products across the full product lifecycle, from early development to post approval. Working closely with cross functional teams, you will shape high quality regulatory documentation, engage with health authorities, and support timely approvals that meet patient and business needs. This role plays a key part in ensuring regulatory excellence and continuous improvement across global markets.
Who you’ll work with
You will be working in a team that brings together regulatory, manufacturing, quality, and supply experts from around the world. The team collaborates closely with other functions in global regulatory affairs, and development, technical and supply teams, creating strong partnerships to support innovative therapies. You will also engage with global stakeholders and external authorities, contributing your expertise across cross-functional projects.
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 explicitly 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 federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Requirements

• A degree in a scientific or technical discipline; advanced or regulatory qualifications are an advantage.
• Extensive experience in pharmaceutical industry and in regulatory roles, including global submissions and working with health authorities supporting regulatory discussions
• Excellence and proven track record of successful regulatory strategic authoring and contribution to delivering regulatory CMC documentation of new marketing authorisations, clinical trial applications and post-approval submissions.
• Experience working with health authorities and supporting regulatory discussions and responses.
• Demonstrated ability to leverage digital tools, structured data, and regulatory information systems to enhance regulatory strategy, submission quality, lifecycle management, and decision‑making across global markets.
• Ability to participate or lead and embed digital and process innovation initiatives within the team, driving harmonization, efficiency, and regulatory excellence across cross‑functional and global teams.

Responsibilities

• Define and deliver regulatory strategies for global or regional specific CMC submissions for assigned projects/products across development and post approval stages.
• Lead complex regulatory submissions, ensuring consistency, quality, and alignment with agreed global strategies.
• Author and review regulatory CMC documentation within agreed timelines.
• Represent regulatory CMC expertise in cross functional project teams and authority interactions, as needed.
• Anticipate risks across the product lifecycle and communicate solutions clearly to key stakeholders.
• Support process improvement initiatives and mentor colleagues within the regulatory team.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees