Make your mark for patients
We are looking for a Global Submission Lead CMC & Devices to join us in our Regulatory Excellence team, based in our Brussels (Belgium) or Slough (UK) offices
About the role
The primary purpose of the Global Submission Lead CMC & Devices is to bring project management solutions to the Global Regulatory Affairs CMC & Devices team. A Global Submission Lead CMC & Devices role is to initiate, to strategically plan, to execute, to monitor/control and to report on the Global Regulatory Affairs CMC & Devices Portfolio activities.
Who you’ll work with
You will report into the Global Submission Team Lead
What you’ll do
Coordinate and lead the development of strategic submission plan with focus on Global Regulatory Affairs CMC & Devices and relevant stakeholders.Create visibility and reporting on Global Regulatory Affairs CMC & Devices portfolio.Plan, track and monitor project progress across all Submission aspects, identifying problems, forecasting risks, and proactively seeking resolutions.Identify internal team synergies and/or conflicts early and propose solutions in agreement with stakeholders (team alignment).Stakeholder management with relevant interfacesScenario planning for the asset/project and PortfolioManage project tools and provide support to the CMC & Devices team, e.g. Integrate, SharePoint, Integrated Project Plan as required by the project.
Interested? For this position you’ll need the following education, experience and skills:
Bachelor’s degreeProject Management techniques & people management in projectsWorking knowledge of the Common Technical Document, drug development processes and Regulatory Filing ProceduresSkilled in communication, leadership and influencing across the organizationStakeholders managementExcellent self-management, priority setting and planning 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 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.
As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com 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.