Hybrid Global Regulatory CMC Scientist—Lead Submissions

UCB S.A.; United Kingdom; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A global biopharmaceutical company in the UK seeks a Regulatory CMC Scientist to define and prepare CMC documentation for regulatory submissions. This role involves leading cross-functional teams, ensuring strategic communication, and contributing to ongoing process improvements. The ideal candidate holds a Bachelor’s or preferably a Master’s in a relevant field, with significant experience in Regulatory Affairs CMC or related areas. A supportive and inclusive work environment is offered, with a hybrid work model.

Benefits

Hybrid work model

Career development opportunities

Inclusive company culture

Qualifications

• Significant relevant experience in pharmaceutical industry, preferably in Regulatory Affairs CMC.
• Proven track record of successful authoring CMC sections of marketing authorisations.
• Knowledge of GMP requirements and analytical development.

Responsibilities

• Author regional and global CMC documentation for regulatory submissions.
• Provide regulatory CMC leadership on cross-functional teams.
• Ensure communication of CMC regulatory strategy to stakeholders.

Skills

Leadership

Communication skills

Problem-solving

Teamwork

Education

Bachelor's degree in life science

Master's degree in life science

Tools

Change management systems

Regulatory documentation tools

Job description

A global biopharmaceutical company in the UK seeks a Regulatory CMC Scientist to define and prepare CMC documentation for regulatory submissions. This role involves leading cross-functional teams, ensuring strategic communication, and contributing to ongoing process improvements. The ideal candidate holds a Bachelor’s or preferably a Master’s in a relevant field, with significant experience in Regulatory Affairs CMC or related areas. A supportive and inclusive work environment is offered, with a hybrid work model.