Overview
As Global Regulatory Affairs CMC Lead, you shape regulatory strategies for early-development biologics, guiding cross-functional teams to ensure timely submissions. You’ll author high-quality CMC content and liaise with Health Authorities, aligning scientific data with business priorities. You drive digital and process improvements to strengthen lifecycle planning. This role offers meaningful impact in a global, collaborative environment focused on patients. You will partner with diverse teams to accelerate development and ensure compliant submissions.
Pay / Benefits
- hybrid work model
- equal opportunity employer
- global exposure
- collaborative culture
- career development opportunities
- supportive, inclusive environment
Responsibilities
- Define global and regional CMC regulatory strategies and submission plans for early-development products
- Author and coordinate CMC content (Modules 2 and 3), and responses to Health Authority questions
- Manage complex submissions, timelines, risks, and cross-functional decisions
- Lead or support CMC interactions and negotiations with Health Authorities
- Monitor regulatory changes and use digital tools/structured data for decisions and lifecycle planning
- Represent Regulatory CMC in project teams and coach colleagues on CMC practices
Key requirements
- Bachelor's degree in a relevant field; five+ years in Regulatory Affairs CMC; 8–10 years in pharmaceutical, medical device, or regulatory authority experience
- Experience contributing to CMC regulatory strategy and clinical trial submissions for biologics/advanced therapies; experience with accelerated development
- Knowledge of global development and post-approval requirements, GMP expectations, and ICH region practices
- Ability to analyze technical data, craft clear regulatory narratives, and manage traceable content across submissions
- Strong communication and negotiation skills with a track record of cross-functional collaboration
- collaborative mindset
- adaptability to changing priorities
- clear communication
- CMC regulatory strategy
- Modules 2 and 3 authoring
- regulatory submissions and Health Authority interactions
Regulatory CMC Lead UK in Slough employer: Ucb Group
UCB is an exceptional employer that fosters a collaborative and innovative work culture, where employees are encouraged to push boundaries and create meaningful value for patients. Located in Slough, our hybrid-first approach allows for flexibility while working alongside experienced scientists in a supportive environment that prioritises personal growth and career development. Join us to be part of a team that values inclusivity and empowers you to make your mark in the biopharmaceutical industry.
