Global Regulatory CMC Lead – Early Development

Meeveem Limited

Slough

Hybrid

GBP 90,000 - 130,000

Full time

7 days ago

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Benefits offered by this job

Hybrid work model

Global team collaboration

Job summary

UCB is seeking a Global Regulatory Affairs CMC Lead - Early Development to shape overall CMC strategy, author submissions, and guide cross-functional teams. The role focuses initially on biologics, with interactions across Health Authorities to ensure timely approval and lifecycle planning.

Hybrid work includes office presence in hubs and flexible scheduling. Ideal candidates will have 5+ years in Regulatory Affairs CMC, 8–10 years in pharma or regulatory roles, and experience with accelerated

Qualifications

Bachelor's degree in a relevant field; master's degree or certificate in regulatory affairs preferred.
At least five years' Regulatory Affairs CMC experience, 8–10 years in pharma, medical devices or regulatory work.
Experience contributing to CMC regulatory strategy and clinical submission sections, including bios/advanced therapies.
Knowledge of global development, post-approval requirements and GMP expectations in at least one ICH region.

Responsibilities

Define and implement global/regional CMC regulatory strategies and submission plans for early-development products.
Author and coordinate CMC content, including Modules 2 and 3, and responses to Health Authority questions.
Lead or support CMC interactions and negotiations with Health Authorities.
Monitor regulatory changes and use data to strengthen lifecycle planning and decision-making.
Represent Regulatory CMC in project teams and coach colleagues.