Global Regulatory CMC Lead, Early Development

Ucb; Slough; Hybrid; GBP 90,000 - 140,000; Full time

Job summary

UCB is seeking a Global Regulatory Affairs, CMC & Devices Lead to shape global CMC strategies for early-development biologics. You will author high-quality submission content, interact with Health Authorities, and align documentation with business priorities.

This role emphasizes cross-functional collaboration and ongoing lifecycle planning. You will work within a hybrid framework, connecting teams across regions and coaching colleagues in regulatory CMC best practices to drive timely

Qualifications

• Bachelor's degree in a relevant field; master's preferred.
• Minimum five years' Regulatory Affairs CMC experience.
• 8–10 years in pharmaceutical, medical device or regulatory-authority roles.
• Experience contributing to CMC regulatory strategy and clinical submission writing.
• Knowledge of global development, GMP standards and ICH regions.

Responsibilities

• Define and implement global/regional CMC strategies and submission plans.
• Coordinate CMC content for Modules 2 and 3 and health authority responses.
• Manage complex submissions, timelines, risks and cross-functional decisions.
• Lead or support CMC interactions and negotiations with health authorities.
• Monitor regulatory changes and improve digital/regulatory lifecycle processes.
• Represent Regulatory CMC in project teams and coach colleagues.

Skills

Regulatory strategy

CMC submissions

Cross-functional collaboration

Regulatory negotiation

Regulatory writing

Education

Bachelor's degree in a relevant field

Master's degree or certificate in regulatory affairs (preferred)

Job description

UCB is seeking a Global Regulatory Affairs, CMC & Devices Lead to shape global CMC strategies for early-development biologics. You will author high-quality submission content, interact with Health Authorities, and align documentation with business priorities.

This role emphasizes cross-functional collaboration and ongoing lifecycle planning. You will work within a hybrid framework, connecting teams across regions and coaching colleagues in regulatory CMC best practices to drive timely