At a Glance
- Tasks: Lead global regulatory strategies for early-development products and engage with health authorities.
- Company: UCB, a global biopharmaceutical company focused on neurology and immunology.
- Benefits: Hybrid work model, supportive culture, and opportunities for career growth.
- Other info: Join a diverse team dedicated to pushing boundaries and creating value.
- Why this job: Make a real impact on patients' lives through innovative regulatory strategies.
- Qualifications: 5+ years in Regulatory Affairs CMC and strong communication skills.
The predicted salary is between 63000 - 77000 £ per year.
Make your mark for patients. We are looking for a Global Regulatory Affairs CMC Lead - Early Development who is strategic, collaborative and adaptable to join our Global Regulatory Affairs, CMC & Devices team, based in any of our Brussels (Belgium), Slough (UK), or Raleigh/Atlanta (US) offices.
About the role:
- You will shape and deliver global regulatory CMC strategies for early-development products, with an initial focus on biologics molecules.
- Working closely with cross functional teams, you will plan and author high-quality regulatory documentation, engage with health authorities, and support timely approvals that meet patient and business needs.
- You will also anticipate risks, respond to regulatory questions and contribute to better digital and regulatory processes.
Who you will work with:
- You will work within the Global Regulatory Affairs, CMC & Devices team that brings together regulatory, manufacturing, quality, and supply experts from around the world.
- You will collaborate with regulatory leads, technical experts and colleagues across regions to align strategy, source documents and submission timelines.
- You are also going to represent the function in cross-functional discussions, support external regulatory interactions and share your expertise by coaching colleagues.
What you will do:
- Define and deliver global and regional CMC regulatory strategies and submissions for assigned early-development products.
- Lead complex regulatory submissions, ensuring consistency, quality, and alignment with agreed global strategies.
- Author and review clear, consistent CMC content, including Modules 2 and 3, responses to Health Authority questions and briefing documents.
- Lead or support CMC interactions and negotiations with Health Authorities, helping teams resolve regulatory issues effectively.
- Anticipate risks across the product lifecycle and communicate solutions clearly to key stakeholders.
- Monitor regulatory changes and use digital tools and structured data to strengthen decisions and lifecycle planning.
- Support process improvement initiatives and coach colleagues within the regulatory team.
Interested? For this role, we are looking for the following education, experience and skills:
- A degree in a relevant field, with at least 5 years in Regulatory Affairs CMC and 8–10 years of relevant pharmaceutical, medical device or regulatory-authority experience.
- Proven contribution to CMC regulatory strategy and authorship of clinical trial submission sections for biological or advanced therapy medicinal products, including accelerated development; marketing authorisation or post-approval submission experience is beneficial.
- Experience working with health authorities and supporting regulatory discussions and responses, underpinned by a solid understanding of global development and post-approval requirements, GMP expectations and regulatory practices in at least one ICH region.
- Able to analyse technical data, create clear regulatory narratives, identify gaps early and manage traceable content across submissions.
- Able to communicate and negotiate clearly, build inclusive cross-functional relationships and remain adaptable as priorities or regulatory expectations evolve.
- Demonstrated ability to leverage digital tools, structured data and regulatory information systems to strengthen strategy, submission quality, lifecycle management and decision-making, and to participate in or lead innovation initiatives that drive harmonisation, efficiency and regulatory excellence across global teams.
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.
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.
Regulatory CMC Lead UK in Princes Risborough employer: Ucb Group
UCB is an exceptional employer that fosters a collaborative and innovative work culture, where employees are encouraged to push boundaries and create meaningful value for patients. Located in Slough, our hybrid-first approach allows for flexibility while working alongside experienced scientists in a supportive environment that prioritises personal growth and career development. Join us to be part of a team that values inclusivity and empowers you to make your mark in the biopharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory CMC Lead UK in Princes Risborough
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We think you need these skills to ace Regulatory CMC Lead UK in Princes Risborough
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Ucb Group!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Ucb Group that you're not just a fit for the job but also a safety-conscious candidate!
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Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Ucb Group, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Ucb Group
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Ucb Group that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
