Global Regulatory CMC Scientist (Raleigh)

Make your mark for patients

We are looking for a Regulatory CMC Scientist to join us in our Global Regulatory team based inour Raleigh NC or Atlanta GA 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 to meet business needs.

Who youll work with

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

What youll do

Responsible for regional and global CMC submissions in line with agreed global regulatory strategy and within agreed timelines.

Contribute and ensure adequate provision of regulatory CMC input to all Health Authority (HA) interactions on CMC matters in all regions

Ensures effective communication of CMC regulatory strategy risks and overall plan to GRA Teams Technical Development and Commercial Teams

Highlights anticipated and ongoing critical issues arising through the product life cycle in a timely manner to senior management to enable communication to key stakeholders

Lead or contribute to ongoing process improvement and department initiatives within the CMC Regulatory Affairs function including process improvements SOP review and development and evaluation/implementation of digital strategies and tools.

Interested For this position youll need the following education experience and skills:

Bachelors degree Masters preferred in a relevant life science or business-related discipline

Demonstrated ability to leverage digital tools structured data and regulatory information systems to enhance CMC and Device regulatory strategy submission quality lifecycle management and decisionmaking across global markets

Significant relevant experience in the pharmaceutical industry preferably in Regulatory Affairs CMC with focus on biological entities

Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological entities

Knowledge of GMP requirements standard systems (e.g. change management systems and tools)

Effective interpersonal presentation and communication skills with established internal and external stakeholders

Proven leadership problem-solving ability flexibility influence and effective teamwork skills.

Are you ready to go beyond to create value and make your mark for patients If this sounds like you then we would love to hear from you!

About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe inspired by patients and driven by science.

Why work with us
At UCB we dont just complete tasks we create value. We arent afraid to push forward collaborate and innovate to make our mark for patients. We have a caring supportive culture where everyone feels included respected and has equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats on our patients our employees or our planet. Working for us you will discover a place where you can grow and have the freedom to carve your own career path to achieve your full potential.

At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employment decisions will be made without regard to any characteristic protected by applicable federal state or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment your employment with UCB or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws orders and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.