Regulatory Scientist
il y a 2 semaines
**Make your mark for patients**
We are looking for a **Regulatory Scientist - Rare Disease** to join us in our **Global Regulatory Affairs** team, based in in either of our Brussels (Belgium) or Slough (UK) offices
**About the role**
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
**Who you’ll work with**
You will report into a Regulatory Science Lead in the Rare Disease team
**What you’ll do**
- 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
I**nterested? For this position you’ll need the following education, experience and skills**:
- Bachelor’s degree required
- Build effective partnerships - identifies opportunities and takes actions to build effective relationships within the team with other areas.
- Influencing skills - through well thought rationale and effective communication skills, able to influence key decisions.
- Flexibility and adaptability - Decide what to do based on the situation. Changes behaviours or approach to fit the situation or the person. Works effectively in ambiguous situations
- Communication skills - knows when and how to communicate, using strong interpersonal skills and written communication when appropriate.
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 8,500 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 equitable 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.
As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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