UCB
Global Regulatory CMC Scientist (UK)
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Global Regulatory CMC Scientist (UK)
Regulatory CMC Scientist
Make your mark for patients.
We are looking for a Regulatory CMC Scientist to join us in our Global Regulatory team, based in Brussels (Belgium), Slough (UK), or Raleigh/Atlanta (US).
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.
What You’ll Do
- Ensure regional and global CMC submissions are completed in line with agreed regulatory strategies and timelines.
- Provide adequate regulatory CMC input to Health Authority (HA) interactions on all CMC matters across regions.
- Communicate the regulatory CMC strategy, risks, and plans to GRA, Technical, Development, and Commercial Teams effectively.
- Highlight anticipated and ongoing critical product life cycle issues to senior management for stakeholder communication.
- Lead or contribute to ongoing process improvement initiatives, including:
- Process improvements
- SOP review and development
- Evaluation and implementation of digital strategies and tools
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Requirements
Education & Experience
- Bachelor’s degree (Master’s preferred) in a relevant life science or business-related discipline.
- Significant industry experience in Regulatory Affairs (CMC), preferably with a focus on biological entities within the pharmaceutical sector.
- Proven ability to highlight potential critical issues through the product life cycle, escalating as necessary.
Skills & Competencies
- Experience leveraging digital tools, structured data, and regulatory information systems to enhance regulatory strategy, submission quality, and lifecycle management.
- Knowledge of GMP requirements and standard regulatory systems (e.g., change management tools).
- Strong interpersonal, communication, and stakeholder management skills at both internal and external levels.
- Problem-solving ability, adaptability, influence, and willingness to work collaboratively in a team.
- Proven leadership and experience authoring contributions to CMC sections of marketing authorisations for new biological entities.
Eligibility (Internal Applicants Only)
- Must have been in current role for at least 12 months.
- Must meet performance standards and not be on a formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning within the last 12 months.
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Company Offer
At UCB, we’ve embraced a hybrid-first approach to work, fostering collaboration in our local hubs.
- 40% office attendance (regardless of contractual arrangements, unless otherwise specified).
- Contact your Talent Partner if your current working agreement differs.
Diversity & Inclusion
UCB is an equal opportunity employer. All employment decisions will be made without regard to protected characteristics under applicable law.
For reasonable accommodation requests during the process, contact EMEA-Reasonable_Accommodation@ucb.com.
Job Details
- Requisition ID: 93423
- Recruiter: Kevin Ross
- Hiring Manager: Wanja Muthoga
- Talent Partner: Bianca Hinshaw
- Job Level: Global Regulatory Association (GRA) II – Mid Management (MM II)
For further details, consult HRAnswers.
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