Regulatory CMC Scientist (UK) (90475)
Regulatory CMC Scientist (UK) (90475)
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Job Description
Make your mark for patients
We are looking for aRegulatory CMC Scientistto join us in ourGlobal Regulatoryteam based in any of ourBrussels(Belgium)Slough(UK) orAtlanta(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 youll work with
You will work within the Regulatory CMC team and partner with other technical functions across the business.
What youll 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 youll need the following education experience and skills:
- Bachelors degree Masters 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 hereR&D at UCB.
RANDATUCB
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 around 8500 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent 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 thats 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 . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Employment Type
Contract
