Global Regulatory CMC Lead, Early Development (Hybrid)

UCB S.A.; Reading; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

UCB is seeking a Global Regulatory Affairs CMC Lead - Early Development to shape global CMC strategies for biologics. The role collaborates across regions to author submissions, respond to health authority questions, and manage lifecycle plans with a hybrid-first work approach.

You will partner with cross-functional teams and coach colleagues while steering regulatory processes in a fast-paced development environment.

Qualifications

• Experience in Regulatory Affairs CMC and strategy development.
• Ability to author regulatory submissions and engage health authorities.
• Strong cross-functional collaboration and risk management.

Responsibilities

• Define and deliver global/regional CMC regulatory strategies and submissions for early-development products.
• Lead complex regulatory submissions with high quality and alignment to global strategies.
• Author and review CMC content including Modules 2 and 3 and health authority responses.
• Lead or support CMC interactions and negotiations with Health Authorities.
• Acknowledge and communicate risks across the product lifecycle to stakeholders.
• Monitor regulatory changes and use digital tools to strengthen decisions and lifecycle planning.
• Support process improvements and coach colleagues within regulatory team.

Skills

Regulatory affairs

CMC expertise

Regulatory strategy

Education

Degree in a relevant field

Job description

UCB is seeking a Global Regulatory Affairs CMC Lead - Early Development to shape global CMC strategies for biologics. The role collaborates across regions to author submissions, respond to health authority questions, and manage lifecycle plans with a hybrid-first work approach.

You will partner with cross-functional teams and coach colleagues while steering regulatory processes in a fast-paced development environment.