Regulatory Science Lead
il y a 3 semaines
**Make your mark for patients.**
We’re here because we want to build the future and transform patients’ lives for the better. To achieve that, we need the brightest minds and biggest hearts. That’s why our Talent Acquisition Team looks for passionate people inside and outside the company. Are you interested in an internal move that will allow you to explore how much more you can do to make a difference for people living with severe disease?
To strengthen our **Global** **Regulatory function**, based in our **Brussels office** we are looking for a talented individual to fill the position of **Regulatory Scientist**.
As a **Regulatory Scientist** you will have the following responsibilities:
- Prepare and deliver regulatory operational plans for assigned projects/products within a specific region as agreed with the Regulatory Scientist Lead / Manager.
- Provide strategic and operational regulatory input and guidance in cross-functional teams. Manage quality regulatory submissions to agreed project targets.
- Work flexibly within and across regions (EU, MENA ) to provide broad operational support to ensure the delivery of product team and business objectives.
- Assist in development of regulatory standards and SOPs / Workshops
- Support the Global Regulatory Scientist Lead for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and regional/local country regulations.
- Respect the planning, coordinate preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
- Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
- Identify potential regulatory risks to the operational plan and propose options to mitigate risks.
- Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
- Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the Global Regulatory Scientist Lead.
Interested? For this position you’ll need the following **education**, **experience** and **skills**:
- Bachelor’s degree
- Several years hands-on experience in Regulatory Affairs, with knowledge of assigned regional regulatory procedures and legislation for complex therapeutics.
- Preferably experience within Life Cycle management & development projects.
- Communication skills - knows when and how to communicate, using strong interpersonal skills and written communications when appropriate.
- Build effective partnerships - identifies opportunities and takes actions to build effective relationships within team and with other areas.
**Why you should apply**
At UCB, we welcome passionate individuals who thrive on change and are ready make their mark for patients. Working for us, you will discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact while putting continuous efforts into cultivating a workplace culture where everyone feels included, respected and has equitable opportunities. Through meaningful recognition and a motivating atmosphere, we aim to provide an optimal experience by caring about and valuing our employees - just as we do for the patients we serve.
RANDATUCB
**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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