Global Submission Lead CMC & Devices

Conteúdo do emprego

Make your mark for patients

We are looking for a Global Submission Lead CMC & Devices to join us in our Regulatory

Community Excellence & Operations team, based in our Brussels (Belgium) offices

About The Role

The Global Submission Lead CMC & Devices initiates and drives both the strategic planning, coordination and the execution of GRA CMC & Devices submissions. This role requires effective collaboration and involves driving the GRA CMC & Devices team to align with the submission plan, ensuring adherence to agreed timelines.

Who You’ll Work With

You will report into the Global Submission Team Lead

What You’ll Do

• Initiate and lead the development of GRA CMC & Devices strategic submission plan.
• Ensure adherence to the submission plan, identifying problems, forecasting risks, and proactively seeking resolutions.
• Manage priorities effectively.
• Manage project tools, e.g. Integrate, Office Timeline Pro, SharePoint, as required by the project.
• Partner with sponsors, stakeholders and teams from GRA CMC & Devices and Patient Supply by building and maintaining strong relationship.

Interested? For this position you’ll need the following education, experience and skills:

• Bachelor’s degree
• Several years of experience from either a cross functional role or from a line function in the pharmaceutical industry, CRO or comparable organization for drug development
• Knowledge of regulatory processes (CTD), in particular CMC & Devices
• Project Management techniques & people management in projects
• Skilled in communication, leadership and influencing across the organization
• Excellent 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 equal 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 is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

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.