Make your mark for patients

 

We are looking for a CMC Development Risk Lead and Regulatory Liaison who is proactive, detail-oriented, and collaborative to join our CMC Development Sciences team, based at our UCB campus in .

 

About the Role

 

As the CMC Development Sciences Risk Lead, you will drive effective risk management by designing, implementing, and continuously improving our departmental risk management framework and governance model. You will ensure that CMC Development Sciences leadership has visibility on key functional risks, informing our strategy and priorities, whilst also managing the escalation of top risks to the Patient Supply Risk Management Committee. You will also foster a risk-aware culture, coaching different levels of the organization to use risk management effectively in decision-making and shaping response strategies.

As the CMC Development Regulatory Liaison, you will coordinate activities related to the preparation of CMC regulatory dossiers for Clinical Trial Applications (IMPDs/INDs) for studies submitted to the appropriate Health Authorities, up to and including Proof of Concept studies. You will ensure that all documents supporting regulatory dossiers are identified and provide guidance on the content to meet all regulatory requirements.

As the CMC Development Sciences representative interfacing with the Regulatory Intelligence Network, you will serve as the central entry point within the department for consultation and implementation of any new or changing regulations related to development activities.

 

Who You Will Work With

 

You will collaborate with a dynamic and diverse team within CMC Development Sciences and the Patient Supply Organisation, working closely with leadership and various stakeholders to ensure effective risk management and regulatory compliance.

 

What You Will Do

 

Drive effective risk management by designing and implementing a risk management framework.Ensure leadership visibility on key functional risks, informing strategy and priorities.Foster a risk-aware culture, coaching the organization on risk management.Coordinate and provide guidance on the preparation of technical documentation supporting the CMC regulatory dossiers for Clinical Trial Applications.Serve as the central entry point for new or changing regulations related to development activities.

 

Interested? For this role, we are looking for the following education, experience, and skills

 

Master’s degree in a relevant scientific discipline with least 5 years' experience in the biopharma industrySolid understanding of the biopharma environment, including chemical / biological, pharmaceutical, technical and analytical aspectsPrevious experience in risk managementHigh level awareness of regulatory requirements for CMC dossier preparationProven project leadership skills, including leadership in a matrix environmentStrong organizational and communication skillsDetail-oriented and proactive.Ability to work collaboratively in a team environment.

 

 

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 around 8,500 people in all four corners of the globe, inspired by patients and driven by science. 

 

Why work with us? 

At UCB, we don’t just complete tasks, we create value. We aren’t 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 equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s 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. 

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
 
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.