Regulatory CMC Scientist (UK)
Posted 1 day 6 hours ago by UCB S.A.
Make your mark for patients
We are looking for a Regulatory CMC Scientist to join our Global Regulatory team, based in any of our Brussels (Belgium), Slough (UK), or Atlanta (US) offices.
About the role
Define the strategy, planning, and preparation (writing and review) of CMC submission documentation for regulatory submissions (new marketing applications, variations) from a global/regional perspective to achieve timely approvals and meet business needs.
Who you'll work with
You will work within the Regulatory CMC team and collaborate with other technical functions across the business.
What you'll do
- Provide regulatory CMC leadership on cross-functional sub teams (Global Regulatory Affairs (GRA) Teams and Technical Teams) and advise on best practices.
- Contribute to and ensure adequate provision of regulatory CMC input for all Health Authority (HA) interactions on CMC matters across regions.
- Communicate CMC regulatory strategy, risks, and overall plans effectively to GRA Teams, Technical, Development, and Commercial Teams.
- Highlight critical issues arising during the product lifecycle to senior management promptly for stakeholder communication.
- Lead or contribute to process improvements and departmental initiatives within the CMC Regulatory Affairs function, including SOP reviews, digital strategies, and tools.
Qualifications, experience, and skills
- Bachelor's degree; Master's preferred in life sciences or related fields.
- Significant experience in pharmaceutical Regulatory Affairs CMC, manufacturing, analytical development, quality assurance/control, or related technical fields, or as a regulatory authority reviewer.
- Proven success in authoring and delivering CMC sections for marketing authorizations of biological or chemical entities.
- Knowledge of GMP standards and change management systems.
- Interest or experience in digitalization, data management, or AI.
- Strong teamwork, communication, and leadership skills, with ability to operate in a matrix organization.
If you want to learn more about R&D at UCB, please visit R&D at UCB .
Are you ready to 'go beyond' to create value and make your mark for patients? If so, we would love to hear from you!
About us
UCB is a global biopharmaceutical company focused on neurology and immunology, with around 8,500 employees worldwide, driven by science and inspired by patients.
Why work with us?
At UCB, we create value through collaboration and innovation. Our inclusive culture fosters growth and career development, with a focus on making a positive impact for patients, employees, and the planet. Join us to grow and pursue your full potential.
UCB is an equal opportunity employer. All employment decisions are made without regard to characteristics protected by law. For accommodations during the application process, contact . Please note this channel is for accommodation requests only.