Global Regulatory Cmc Scientist
il y a 2 jours
**Make your mark for patients.**
We’re here because we want to build the future and transform patients’ lives for the better.
At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.
An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?
To strengthen our Regulatory Affairs Group, we are looking to fill the position of: Global Regulatory CMC Scientist - Small Molecules.
What We Offer
An opportunity to:
- Take responsibility for the regulatory CMC support of Small Molecule products throughout the Life-Cycle.
- Define strategy, planning and preparation of regional specific CMC submission documentation for assigned geographical regions and contribute to the preparation of global submission documentation to deliver timely approvals to meet business needs.
- Leading and/or provide regulatory CMC input to all Health Authorities (HA) interactions on CMC matters in assigned regions as delegated by Global Regulatory CMC Lead and agreed with the GRA Leadership Team and the operating units.
About the Role
You will be responsible for:
- Developing and implementing the regional CMC regulatory strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.
- Taking “Hands-on” accountability by managing CMC projects yourself and writing regional and global CMC documentation for submissions in line with agreed global regulatory strategy, and within agreed timelines
- Ensuring effective communication of CMC regulatory strategy, risks, and overall plan for assigned regions to GRA Teams, Technical & Supply Operations (TSO) Teams, Development and Commercial Teams as agreed with the Global Regulatory CMC Lead
- Identifying supporting CMC documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
- Responsible for regulatory assessments for CMC changes and creation of entries and updates in the designated systems (Trackwise, UPILOT, etc.) within defined timelines.
About You
You should have:
- Educated to a master’s level, in a relevant life science or business-related discipline
- Experience in the pharmaceutical industry or a regulatory authority 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.
**About us.**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.
At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
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