At a Glance
- Tasks: Define and prepare CMC submission documentation for global regulatory approvals.
- 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.
- Other info: Collaborative culture with a focus on inclusion and equal opportunities.
- Why this job: Make a real impact on patients' lives through innovative regulatory strategies.
- Qualifications: Bachelor’s degree in life sciences; experience in Regulatory Affairs CMC preferred.
The predicted salary is between 50000 - 65000 € per year.
Make your mark for patients. 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 and regulatory functions across the business.
What you’ll do:
- Responsible for regional and global CMC submissions in line with agreed global regulatory strategy, and within agreed timelines.
- 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.
- Demonstrated ability to leverage digital tools, structured data, and regulatory information systems to enhance CMC and Device regulatory strategy, submission quality, lifecycle management, and decision‑making across global markets.
- Significant relevant experience in the pharmaceutical industry preferably in Regulatory Affairs CMC with focus on chemical entities.
- Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new 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.
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.
Regulatory CMC Scientist in Slough employer: UCB
UCB is an exceptional employer that prioritises a supportive and inclusive work culture, allowing employees to thrive while making a meaningful impact on patients' lives. With a strong focus on collaboration and innovation, UCB offers ample opportunities for professional growth and development, all within a hybrid work environment that fosters teamwork and creativity. Join us in Brussels or Slough, where you can carve your own career path and contribute to groundbreaking advancements in neurology and immunology.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory CMC Scientist 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 what it’s really like to work there.
✨Tip Number 2
Prepare for interviews by diving deep into CMC regulations and recent trends in the pharmaceutical industry. Show us you’re not just knowledgeable but also passionate about making a difference for patients.
✨Tip Number 3
Practice your communication skills! You’ll need to convey complex regulatory strategies clearly. Try explaining your ideas to friends or family to get comfortable with your delivery.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team.
We think you need these skills to ace Regulatory CMC Scientist in Slough
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Regulatory CMC Scientist role. Highlight your relevant experience in regulatory submissions and any specific skills that align with the job description. We want to see how you can make your mark for patients!
Showcase Your Experience:When detailing your past roles, focus on your achievements in CMC submissions and any successful authoring of marketing authorisations. Use specific examples to demonstrate your expertise and how you've contributed to process improvements in previous positions.
Be Clear and Concise:Keep your application clear and to the point. Use straightforward language and avoid jargon unless it's relevant to the role. We appreciate a well-structured application that makes it easy for us to see your qualifications at a glance.
Apply Through Our Website:We encourage you to apply directly through our website. This ensures your application is received properly and allows us to review it efficiently. Plus, it shows you're keen on joining our team at UCB!
How to prepare for a job interview at UCB
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of CMC submissions and regulatory strategies. Be prepared to discuss specific examples from your past experience where you've successfully authored CMC sections for marketing authorisations. This will show that you understand the nuances of the role and can hit the ground running.
✨Showcase Your Digital Savvy
Since the role requires leveraging digital tools and structured data, be ready to talk about your experience with regulatory information systems. Highlight any specific tools you've used and how they improved submission quality or decision-making in your previous roles.
✨Communicate Effectively
Effective communication is key in this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory strategies. You might even want to prepare a few scenarios where you had to communicate critical issues to stakeholders, showcasing your interpersonal skills.
✨Emphasise Process Improvement
The job mentions ongoing process improvement initiatives, so think about times when you've contributed to enhancing processes in your previous roles. Be ready to share specific examples of how you identified issues and implemented solutions, demonstrating your proactive approach to continuous improvement.
