Global Regulatory Affairs CMC Lead

Make your mark for patients

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/Raleigh (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 youll 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.

What youll do

• 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.

Interested For this position youll need the following education experience and skills:

• 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 decisionmaking 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 crossfunctional and global teams.

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 dont just complete tasks we create value. We arent 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 thats 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 weve 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 Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.