We are looking for a Regulatory CMC Scientist to join our Global Regulatory team, based in any of our Brussels (Belgium) or Slough (UK) 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 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.
Qualifications
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
We would love to hear from you if this sounds like you!
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 EMEA-Reasonable_Accommodation@ucb.com. Please note if your enquiry does not relate to adjustments, we will not be able to support you through this channel.
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