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- Tasks: Lead regulatory submissions and ensure timely approvals for new products.
- Company: UCB is a global biopharmaceutical company focused on neurology and immunology.
- Benefits: Enjoy a supportive culture, career growth opportunities, and a focus on innovation.
- Why this job: Make a real impact on patients' lives while collaborating in a dynamic team environment.
- Qualifications: Bachelorâs degree required; experience in pharmaceutical industry preferred.
- Other info: Join a diverse team dedicated to pushing boundaries and creating value.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Join to apply for the Regulatory CMC Scientist (UK) role at UCB
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Join to apply for the Regulatory CMC Scientist (UK) role at UCB
Make your mark for patients
We are looking for a
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), Slough (UK), or Atlanta (US) 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 Youâll Work With
You will work within the Regulatory CMC team and partner with other technical functions across the business.
What Youâll Do
- 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
- Ensures effective communication of CMC regulatory strategy, risks, and overall plan to GRA Teams, Technical, Development and Commercial Teams
- Highlights 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 youâll need the following education, experience and skills:
- Bachelorâs degree, Masterâs 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)
- Experience and/or interest in digitalization, data management, and/or artificial intelligence
- Demonstrated competence in contributing in cross-functional teams and operating within a matrix organisational structure
- Effective interpersonal, presentation and communication skills with established internal and external stakeholders
- Proven leadership, problem-solving ability, flexibility, influence, and effective teamwork skills.
If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB .
RANDATUCB
Are you ready to âgo beyondâ 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 around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we donât just complete tasks, we create value. We arenât 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 âgo beyondâ to create value for our patients, and always with a human focus, whether thatâs 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.
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
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Seniority level
Mid-Senior level
Employment type
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Employment type
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Job function
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Job function
Research
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Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Regulatory CMC Scientist (UK) employer: UCB
Contact Detail:
UCB Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Regulatory CMC Scientist (UK)
â¨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those working in Regulatory Affairs. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in CMC submissions.
â¨Tip Number 2
Familiarise yourself with the specific regulatory requirements and guidelines relevant to CMC submissions in the UK and Europe. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
â¨Tip Number 3
Prepare to discuss your experience with cross-functional teams during interviews. Highlight specific examples where you successfully collaborated with different departments to achieve regulatory goals.
â¨Tip Number 4
Stay updated on digitalisation trends in the pharmaceutical industry, particularly those related to data management and artificial intelligence. Being knowledgeable in these areas can set you apart from other candidates.
We think you need these skills to ace Regulatory CMC Scientist (UK)
Some tips for your application đŤĄ
Tailor Your CV: Make sure your CV highlights relevant experience in Regulatory Affairs CMC and any specific achievements in the pharmaceutical industry. Use keywords from the job description to align your skills with what UCB is looking for.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for making a mark for patients. Mention how your background aligns with UCB's mission and values.
Showcase Leadership Skills: In your application, provide examples of your leadership and teamwork experiences. Highlight situations where you contributed to cross-functional teams or led initiatives that improved processes within Regulatory Affairs.
Proofread and Edit: Before submitting your application, thoroughly proofread all documents. Check for grammatical errors, clarity, and ensure that your application presents a professional image. A polished application reflects your attention to detail.
How to prepare for a job interview at UCB
â¨Understand the Regulatory Landscape
Familiarise yourself with the current regulatory environment, especially in CMC submissions. Be prepared to discuss recent changes in regulations and how they might impact UCB's operations.
â¨Showcase Your Cross-Functional Experience
Highlight your experience working in cross-functional teams. Provide examples of how you've collaborated with different departments to achieve regulatory goals, as this role requires effective communication across various teams.
â¨Prepare for Technical Questions
Expect technical questions related to CMC documentation and regulatory submissions. Brush up on your knowledge of GMP requirements and be ready to discuss your previous experiences in authoring CMC sections for marketing authorisations.
â¨Demonstrate Problem-Solving Skills
Be ready to share specific examples of challenges you've faced in regulatory affairs and how you overcame them. UCB values flexibility and problem-solving abilities, so showcasing these skills will set you apart.
