Global Regulatory CMC Scientist

Global 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.

What you’ll do:

• Responsible for authoring regional and global CMC documentation for submissions in line with agreed global regulatory strategy, and within agreed timelines
• 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)
• Effective interpersonal, presentation and communication skills with established internal and external stakeholders
• Proven leadership, problem-solving ability, flexibility, influence, and effective teamwork skills