Global CMC Regulatory Lead, Early Development (Biologics)

UCB; Slough; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

UCB is seeking a Global Regulatory Affairs CMC Lead - Early Development to shape global regulatory CMC strategies for early-development biologics. You will collaborate with cross-functional teams across regions to plan, author and submit high-quality regulatory documentation and engage health authorities to enable timely approvals.

Based in a hybrid setup with offices in Slough, Brussels or Raleigh/Atlanta as possible, you will monitor regulatory changes, coach colleagues, and drive lifecycle

Qualifications

• A degree in a relevant field with at least 5 years in Regulatory Affairs CMC.
• 8–10 years of relevant pharmaceutical, medical device or regulatory-authority experience.
• Experience with health authorities and regulatory discussions.
• GMP understanding and regional ICH experience.

Responsibilities

• Define and deliver global and regional CMC regulatory strategies and submissions for assigned early-development products.
• Lead complex regulatory submissions, ensuring consistency, quality, and alignment with agreed global strategies.
• Author and review clear, consistent CMC content, including Modules 2 and 3, responses to Health Authority questions and briefing documents.
• Lead or support CMC interactions and negotiations with Health Authorities, helping teams resolve regulatory issues effectively.
• Anticipate risks across the product lifecycle and communicate solutions clearly to key stakeholders.
• Monitor regulatory changes and use digital tools and structured data to strengthen decisions and lifecycle planning.
• Support process improvement initiatives and coach colleagues within the regulatory team.

Skills

Regulatory strategy

CMC expertise

Authoring regulatory submissions

Health Authority interactions

Cross-functional collaboration

Digital tools usage

Education

Degree in a relevant field

Job description

UCB is seeking a Global Regulatory Affairs CMC Lead - Early Development to shape global regulatory CMC strategies for early-development biologics. You will collaborate with cross-functional teams across regions to plan, author and submit high-quality regulatory documentation and engage health authorities to enable timely approvals.

Based in a hybrid setup with offices in Slough, Brussels or Raleigh/Atlanta as possible, you will monitor regulatory changes, coach colleagues, and drive lifecycle