Regulatory CMC Scientist

Regulatory CMC Scientist

UCB - Union Chimique Belge

Brussels or Slough

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.

Who you’ll work with

You will work within the Regulatory CMC team and partner with other technical and regulatory functions across the business.

What you’ll do

• Responsible for regional and global CMC submissions in line with agreed global regulatory strategy, and within agreed timelines;
• 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;
• Demonstrated ability to leverage digital tools, structured data, and regulatory information systems to enhance CMC and Device regulatory strategy, submission quality, lifecycle management, and decision‑making across global markets;
• Significant relevant experience in the pharmaceutical industry preferably in Regulatory Affairs CMC with focus on chemical entities;
• Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new chemical entities;
• Knowledge of GMP requirements, standard systems (e.g. change management systems and tools);
• Effective interpersonal, presentation and communication skills with established internal and external stakeholders.