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For Companies At a Glance
- Tasks: Lead the strategy and preparation of regulatory submissions in a dynamic global team.
- Company: Join UCB, a global biopharmaceutical leader focused on neurology and immunology.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for personal growth.
- Why this job: Make a real impact on patients' lives while advancing your career in a supportive environment.
- Qualifications: Bachelor's degree required; experience in Regulatory Affairs CMC preferred.
- Other info: Collaborative culture with a focus on innovation and inclusivity.
The predicted salary is between 36000 - 60000 £ per year.
We are looking for a Regulatory CMC Scientist to join us in our Global Regulatory team, based in any of our Brussels (Belgium) or Slough (UK) offices.
About The Role
Define the strategy, planning and preparation (writing and review) of CMC submission documentation for regulatory submissions (new marketing applications, variations) from a global/regional perspective to achieve timely approvals to meet business needs.
Who You’ll Work With
You will work within the Regulatory CMC team and partner with other technical functions across the business.
What You’ll Do
- Responsible for authoring regional and global CMC documentation for submissions in line with agreed global regulatory strategy, and within agreed timelines.
- Provide regulatory CMC leadership on the cross functional sub teams (Global Regulatory Affairs (GRA) Teams and Technical Teams) and advise on best practices.
- Contribute and ensure adequate provision of regulatory CMC input to all Health Authority (HA) interactions on CMC matters in all regions.
- Ensure effective communication of CMC regulatory strategy, risks, and overall plan to GRA Teams, Technical, Development and Commercial Teams.
- Highlight anticipated and ongoing critical issues arising through the product life cycle in a timely manner to senior management to enable communication to key stakeholders.
- Lead or contribute to ongoing process improvement and department initiatives within the CMC Regulatory Affairs function, including process improvements, SOP review and development, and evaluation/implementation of digital strategies and tools.
Interested? For this position you’ll need the following education, experience and skills:
- Bachelor’s degree, Master’s preferred in a relevant life science or business-related discipline.
- Significant relevant experience in the pharmaceutical industry preferably in Regulatory Affairs CMC and/or in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field, or as a regulatory authority in a CMC review capacity.
- Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities.
- Knowledge of GMP requirements, standard systems (e.g. change management systems and tools).
- Effective interpersonal, presentation and communication skills with established internal and external stakeholders.
- Proven leadership, problem-solving ability, flexibility, influence, and effective teamwork 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 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 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.
Global Regulatory CMC Scientist (UK) in Slough employer: UCB
Contact Detail:
UCB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Regulatory CMC Scientist (UK) in Slough
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working at UCB. A friendly chat can open doors and give you insider info on the role.
✨Tip Number 2
Prepare for interviews by brushing up on your CMC knowledge. Be ready to discuss your past experiences and how they align with UCB's goals. Show us you’re passionate about regulatory affairs!
✨Tip Number 3
Don’t just wait for job postings! Keep an eye on our website and apply directly. We love proactive candidates who take the initiative to reach out.
✨Tip Number 4
Practice your communication skills. You’ll need to convey complex ideas clearly, so consider mock interviews or even chatting with friends to refine your pitch.
We think you need these skills to ace Global Regulatory CMC Scientist (UK) in Slough
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in Regulatory Affairs CMC. Use keywords from the job description to show that you understand what we're looking for.
Showcase Your Achievements: Don’t just list your responsibilities; share specific examples of your successes in authoring CMC documentation or leading cross-functional teams. We love to see how you've made an impact!
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key points stand out.
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at UCB
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of CMC documentation and regulatory submissions. Be prepared to discuss specific examples from your past experience where you've successfully authored or contributed to CMC sections. This will show that you not only understand the requirements but can also apply them effectively.
✨Showcase Your Leadership Skills
Since the role involves providing regulatory CMC leadership, think of instances where you've led cross-functional teams or projects. Be ready to share how you influenced decisions and drove improvements. This will demonstrate your ability to lead and collaborate effectively within a team.
✨Communicate Clearly and Confidently
Effective communication is key in this role. Practice articulating your thoughts clearly, especially when discussing complex regulatory strategies or issues. Use examples to illustrate your points, and don’t shy away from asking questions to clarify any uncertainties during the interview.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities and flexibility. Think about potential challenges you might face in the role and how you would address them. This will help you showcase your critical thinking skills and readiness to tackle real-world issues.
