Global Regulatory CMC Lead - Early Biologics (Hybrid)

UCB S.A.; Princes Risborough; Hybrid; GBP 110,000 - 140,000; Full time

Job summary

UCB S.A. is seeking a Global Regulatory Affairs CMC Lead - Early Development to shape and deliver regulatory CMC strategies for early-stage biologics. You will collaborate with cross-functional teams to author high-quality submissions and engage Health Authorities to drive timely approvals.

You will lead complex submissions, manage risk, and leverage digital tools to improve lifecycle planning while coaching colleagues across regions in a hybrid, global work environment.

Qualifications

• Degree in a relevant field required.
• Proven track record in Regulatory Affairs CMC and submissions.
• Experience with health authorities and global development requirements.
• Ability to analyse technical data and craft regulatory narratives.

Responsibilities

• Define and deliver global/regional CMC strategies and submissions.
• Lead complex regulatory submissions with focus on quality and alignment.
• Author/review Modules 2 and 3 and responses to Health Authority questions.
• Lead or support CMC interactions with Health Authorities and negotiate effectively.
• Anticipate risks and communicate solutions to stakeholders.
• Monitor regulatory changes and leverage digital tools for lifecycle planning.
• Coach colleagues within regulatory teams.

Skills

CMC Regulatory

Regulatory strategy

Health Authority liaison

Regulatory submissions

GMP knowledge

Data/Regulatory systems

Cross-functional leadership

Negotiation

Technical data analysis

Education

Degree in a relevant field

Tools

eCTD tools

RIM (Regulatory Information Management)

Health Authority portals

Job description

UCB S.A. is seeking a Global Regulatory Affairs CMC Lead - Early Development to shape and deliver regulatory CMC strategies for early-stage biologics. You will collaborate with cross-functional teams to author high-quality submissions and engage Health Authorities to drive timely approvals.

You will lead complex submissions, manage risk, and leverage digital tools to improve lifecycle planning while coaching colleagues across regions in a hybrid, global work environment.