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- Tasks: Lead regulatory strategy and submissions for innovative pharmaceutical products.
- 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 patient lives while working with cutting-edge technology.
- Qualifications: Experience in regulatory affairs and strong communication skills required.
- 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 Global Regulatory CMC Lead to join us in our Regulatory Affairs team, based in either our Brussels (Belgium) or Slough (UK) offices.
About The Role
The Global Regulatory Affairs CMC Lead is responsible for defining strategy, planning and preparation of regional specific CMC submission documentation on developed products, for assigned geographical regions and contributing to the preparation of global submission documentation to deliver timely approvals to meet business needs.
Responsible for authoring of the Module 3 components based on source document and Modules 2 for assigned developed products/projects, including new submissions and response to Questions from Health Authorities. He/she follows the process from creation, through review & approval and delivery of final documentation to the appropriate function.
Who You’ll Work With
You will report into a Global Regulatory Affairs CMC Team Lead
What You’ll Do
- Develop and implement the CMC & Devices regulatory strategy and submission plans for assigned developed projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.
- Lead complex projects and submissions, ensuring comprehensive regulatory CMC/Medical Device input is provided, and deliver results in a timely manner aligned with the regulatory strategy agreed with the Team Lead, Global Regulatory Affairs CMC & Devices Leadership, and Global Regulatory Lead.
- Identify supporting documents required for (global) submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Ensure that the regional CMC/Medical Device regulatory strategy for the assigned projects/products is consistent with the Global Regulatory Affairs, supply and patient value goals and meets Health Authority requirements in assigned regions.
- Write regional and global CMC/Medical Device documentation for submissions as agreed with the Team Lead, in line with agreed global regulatory strategy, and within agreed timelines.
Interest in education, experience and skills:
- Several years of relevant experience in the pharmaceutical industry (manufacturing, analytical development, and quality assurance/control or related technical field) or a regulatory authority in a CMC/Medical Device review capacity, with experience in Regulatory Affairs CMC/
- Proven track record of successful authoring and contribution to delivering CMC sections of post-approval submissions for biological and/or chemical entities
- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on post-approval products
- Experience of direct communication and negotiation with regulatory agencies on CMC/Medical Device matters
- Experience of participating in regulatory agency meetings on CMC/Medical Device matters
- Demonstrated competence in leading/contributing on cross-functional teams and operating within a matrix organisational structure.
- Experience and/or interest in digitalization, data management, and/or artificial intelligence
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.
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Legal and Research
- Industries: Pharmaceutical Manufacturing
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Global Regulatory CMC Lead (UK) employer: UCB
Contact Detail:
UCB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Regulatory CMC Lead (UK)
✨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 the interview by knowing your stuff! Brush up on CMC regulations and recent developments in the pharmaceutical industry. Show us you’re passionate and informed!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online platforms. Get comfortable talking about your experience and how it relates to the Global Regulatory CMC Lead role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take that extra step!
We think you need these skills to ace Global Regulatory CMC Lead (UK)
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Global Regulatory CMC Lead role. Highlight your relevant experience in regulatory affairs and any specific projects that align with the job description. We want to see how you can bring value to our team!
Showcase Your Skills: Don’t just list your skills; demonstrate them! Use examples from your past experiences to show how you've successfully led complex projects or communicated with regulatory agencies. This will help us understand your capabilities better.
Be Clear and Concise: When writing your application, keep it clear and to the point. Avoid jargon unless it's necessary, and make sure your key achievements stand out. We appreciate straightforward communication, especially in regulatory roles!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at UCB
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of CMC (Chemistry, Manufacturing, and Controls) regulations. Familiarise yourself with the specific requirements for the regions you'll be working in, especially if you're applying for a role that involves global submissions. This will show your potential employer that you're not just interested in the role, but that you understand the complexities involved.
✨Prepare for Scenario-Based Questions
Expect to face scenario-based questions during your interview. Think about past experiences where you've led complex projects or negotiated with regulatory agencies. Prepare specific examples that highlight your problem-solving skills and ability to work within a matrix organisational structure. This will help you demonstrate your competence effectively.
✨Showcase Your Cross-Functional Team Experience
Since the role involves working with cross-functional teams, be ready to discuss your experience in this area. Highlight instances where you've collaborated with different departments to achieve a common goal. This will illustrate your ability to lead and contribute effectively in a team setting, which is crucial for the Global Regulatory CMC Lead position.
✨Express Your Interest in Digitalisation
Given the emphasis on digitalisation and data management in the job description, make sure to express your interest and any relevant experience in these areas. Discuss how you see technology playing a role in improving regulatory processes. This will show that you're forward-thinking and aligned with the company's goals of innovation and value creation.
