Quick overview
Job description
JOB DESCRIPTION
Make your mark for patients
About the role
You will provide EU regulatory expertise for product information and promotional review. You will keep EU Product Information accurate and up to date- covering the SmPC, Label, PIL, and IFU. You are going to help teams turn data into clear, compliant text for healthcare professionals and patients, supporting patient safety and regulatory expectations.
Who you’ll work with
You will work with EU and Global Regulatory colleagues and partner with Medical, Legal, Commercial, Safety, and Quality teams. You are going to collaborate with Strategic Partners in Country, artwork and packaging colleagues, and external vendors supporting translations and readability testing.
What you’ll do
You will create and maintain EU Product Information aligned with CCDS, RTQs, templates, and SOPs in ECMS.
You will be the EU point of contact and represent EU labeling in cross-functional forums.
You will coordinate reviews and approvals, tracking changes and timelines.
You will manage readability testing end-to-end.
You will coordinate linguistic review, closing sequence, and artwork changes.
You will review promotional materials for compliance with EU labeling and regulations.
Interested? For this position you’ll need the following education, experience and skills:
- Degree in life sciences, pharmacy, healthcare, or a related field.
- Around 3-5 years of regulatory affairs experience.
- Clear written and verbal communication skills.
- Strong collaboration and stakeholder engagement.
- Ability to manage multiple priorities.
- High standards of integrity and quality focus
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 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.
At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly 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 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 Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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