Regulatory Scientist

工作内容

To strengthen our Global Regulatory Affairs function, based in our Brussels, Belgium offices 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
• Hands-on experience in Regulatory Affairs, with knowledge of assigned regional regulatory procedures and legislation
• Experience within Life Cycle management and/or development projects.
• Flexibility and adaptability: Able to support decision making with confidence to instinctively change behavior or approach to fit the situation or the person – work effectively in ambiguous situations.
• Communication skills: Know when and how to communicate, using strong interpersonal and written communication skills when appropriate.
• Results focused: Possesses the ability to overcome obstacles and achieve key outcomes.
• Analytical skills: Logically break situations or issues down into their essential elements, carrying out diagnosis and developing solutions
• Influencing skills: through well thought through rationale and effective communication skills, able to influence key decisions.
• Organizational skill: Maintains a high level of attention to detail.
• Integrity: Have an overriding commitment to integrity and high standards in self and others.
• Builder of effective partnerships: Identify opportunities and take actions to build effective relationships within team, as well as, with external partners.

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.

If you believe that you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.