Head of EU Regulatory Affairs

Job title:

Head of EU Regulatory Affairs

Company:

UCB

Job description

Make your mark for patientsWe are looking for a Head of EU Regulatory Affairs to lead our European Regulatory team. The position is based in our HQ in Brussels, BelgiumAbout the roleThe Head of EU Regulatory Affairs provides regulatory oversight for therapeutic/disease area(s), senior leadership and mentorship for regulatory science staff, within the EU region. The Head of EU Regulatory Affairs will work with Patient Value Unit leadership to provide therapeutic area regulatory strategies and disease state insights; regulatory vision and direction to add patient value and product differentiation; recommendations to optimize the portfolio; and leadership to establish an external network to keep abreast of trends affecting UCB’s portfolio.Who you’ll work withYou will report into the Head of Global Regulatory AffairsWhat you’ll do

• Recruit, develop, and retain highly talented and skilled regulatory scientists
• Responsible for providing regulatory leadership specific to the EU therapeutic/disease area strategies to Patient Value Unit leadership.
• Ensures regulatory resources are provided for early, late-stage development and life cycle projects (in conjunction with the Head of Global Regulatory Strategy & team of Global Regulatory Leads).
• Ensure that regulatory therapeutic/disease area strategic options, assessments, and risks specific to the EU are communicated to the Patient Value Units.
• Accountable for achieving EU regulatory alignment for disease area regulatory strategy with input from patient value unit leadership, members of the global regulatory affairs leadership team and Regional Leads.
• Liaise with Global Business Development regarding therapy area Due Diligence assignments and provide input to due diligence projects as required.
• Responsible for developing credible and trustful relationships internally and externally, with specific emphasis on the EMA

Interested? For this position you’ll need the following education, experience and skills:

• Bachelor’s degree required
• Significant pharmaceutical industry experience in regulatory affairs
• EU regulatory experience (Americas, Middle East & Africa; Asia Pacific a plus) required with a proven track record of significant regulatory accomplishments
• Thorough understanding of drug development process and global regulatory requirements and processes
• Up to date knowledge of the EU regulatory environment; thorough understanding of the complex set of regulations within which the organization operates and awareness of the subtleties of regulations worldwide.
• Up to date knowledge and appreciation of the science driving drug discovery & development processes and product lifecycles.

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.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Expected salary

Location

Anderlecht, Bruxelles

Job date

Thu, 15 Aug 2024 03:20:00 GMT

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