MAKE YOUR MARK FOR PATIENTS

We are looking for a Regulatory CMC Scientist to join us in our Global Regulatory team, based in any of our Brussels (Belgium), Slough (UK), or Atlanta (US) offices.

ABOUT US

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Interested? For this position you’ll need the following education, experience and skills:

• Bachelor’s degree, Master’s preferred in a relevant life science or business-related discipline
• Significant relevant experience in the pharmaceutical industry preferably in Regulatory Affairs CMC and/or in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field, or as a regulatory authority in a CMC review capacity
• Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
• Knowledge of GMP requirements, standard systems (e.g. change management systems and tools)
• Experience and/or interest in digitalization, data management, and/or artificial intelligence
• Demonstrated competence in contributing in cross-functional teams and operating within a matrix organisational structure
• Effective interpersonal, presentation and communication skills with established internal and external stakeholders
• Proven leadership, problem-solving ability, flexibility, influence, and effective teamwork skills

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 to meet business needs.

WHAT YOU’LL DO

• Provide regulatory CMC leadership on the cross functional sub teams (Global Regulatory Affairs (GRA) Teams and Technical Teams and advise on best practices
• Contribute and ensure adequate provision of regulatory CMC input to all Health Authority (HA) interactions on CMC matters in all regions
• Ensures effective communication of CMC regulatory strategy, risks, and overall plan to GRA Teams, Technical, Development and Commercial Teams
• Highlights anticipated and ongoing critical issues arising through the product life cycle in a timely manner to senior management to enable communication to key stakeholders
• Lead or contribute to ongoing process improvement and department initiatives within the CMC Regulatory Affairs function, including process improvements, SOP review and development, and evaluation/implementation of digital strategies and tools.

Interested? For this position you’ll need the following education, experience and skills:

• Bachelor’s degree, Master’s preferred in a relevant life science or business-related discipline
• Significant relevant experience in the pharmaceutical industry preferably in Regulatory Affairs CMC and/or in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field, or as a regulatory authority in a CMC review capacity
• Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
• Knowledge of GMP requirements, standard systems (e.g. change management systems and tools)
• Experience and/or interest in digitalization, data management, and/or artificial intelligence
• Demonstrated competence in contributing in cross-functional teams and operating within a matrix organisational structure
• Effective interpersonal, presentation and communication skills with established internal and external stakeholders
• Proven leadership, problem-solving ability, flexibility, influence, and effective teamwork skills.

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.