Regulatory CMC Scientist (UK)

UCB S.A.; Slough; On-site; GBP 40,000 - 70,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Regulatory CMC Scientist to join their Global Regulatory team in Slough. The role involves defining strategies for CMC submissions and collaborating with various teams to ensure timely approvals. Candidates should have a strong background in Regulatory Affairs and excellent communication skills to navigate complex regulatory environments.

Qualifications

• Significant experience in pharmaceutical Regulatory Affairs CMC.
• Proven success in authoring CMC sections for marketing authorizations.
• Knowledge of GMP standards and change management systems.

Responsibilities

• Provide regulatory CMC leadership on cross-functional teams.
• Ensure adequate regulatory CMC input for Health Authority interactions.
• Communicate CMC regulatory strategy and risks effectively.

Skills

Teamwork

Communication

Leadership

Digitalization

Data Management

Education

Bachelor’s degree in life sciences

Master’s degree preferred

Job description

Make your mark for patients

We are looking for a Regulatory CMC Scientist to join our Global Regulatory team, based in any of our Brussels (Belgium), Slough (UK), or Atlanta (US) offices.

About the role

Define the strategy, planning, and preparation (writing and review) of CMC submission documentation for regulatory submissions (new marketing applications, variations) from a global/regional perspective to achieve timely approvals and meet business needs.

Who you’ll work with

You will work within the Regulatory CMC team and collaborate with other technical functions across the business.

What you’ll do

• Provide regulatory CMC leadership on cross-functional sub teams (Global Regulatory Affairs (GRA) Teams and Technical Teams) and advise on best practices.
• Contribute to and ensure adequate provision of regulatory CMC input for all Health Authority (HA) interactions on CMC matters across regions.
• Communicate CMC regulatory strategy, risks, and overall plans effectively to GRA Teams, Technical, Development, and Commercial Teams.
• Highlight critical issues arising during the product lifecycle to senior management promptly for stakeholder communication.
• Lead or contribute to process improvements and departmental initiatives within the CMC Regulatory Affairs function, including SOP reviews, digital strategies, and tools.

Qualifications, experience, and skills

• Bachelor’s degree; Master’s preferred in life sciences or related fields.
• Significant experience in pharmaceutical Regulatory Affairs CMC, manufacturing, analytical development, quality assurance/control, or related technical fields, or as a regulatory authority reviewer.
• Proven success in authoring and delivering CMC sections for marketing authorizations of biological or chemical entities.
• Knowledge of GMP standards and change management systems.
• Interest or experience in digitalization, data management, or AI.
• Strong teamwork, communication, and leadership skills, with ability to operate in a matrix organization.

If you want to learn more about R&D at UCB, please visit R&D at UCB.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If so, we would love to hear from you!

About us

UCB is a global biopharmaceutical company focused on neurology and immunology, with around 8,500 employees worldwide, driven by science and inspired by patients.

Why work with us?

At UCB, we create value through collaboration and innovation. Our inclusive culture fosters growth and career development, with a focus on making a positive impact for patients, employees, and the planet. Join us to grow and pursue your full potential.

UCB is an equal opportunity employer. All employment decisions are made without regard to characteristics protected by law. For accommodations during the application process, contact [e-mail]. Please note this channel is for accommodation requests only.