EU Regulatory Science Lead

UCB; Brussel; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

UCB in Brussels, Belgium seeks an EU Regulatory Science Lead to drive EU regulatory strategy across development, approval and lifecycle activities. You will be the main EU regulatory contact for health authority interactions, including EMA.

You will work with Global Regulatory Affairs and cross-functional teams to shape plans, identify risks and support timely submissions and informed decision-making in a dynamic policy environment.

Qualifications

• Degree in life sciences, pharmacy, medicine, law or regulatory field.
• Strong experience in EU regulatory affairs including product development, marketing authorisations and lifecycle management.
• Understanding of EU regulatory frameworks, procedures and health authority expectations.
• Ability to translate complex regulatory information into clear recommendations for audiences.
• Ability to work across functions and cultures and build alignment with evidence and credibility.

Responsabilités

• Develop and implement EU regulatory strategies aligned with business objectives and global regulatory plans.
• Coordinate EU submission activities in line with regulations, timelines and strategies.
• Manage EU regulatory risks by identifying options and supporting mitigation plans.
• Act as the key EU contact for assigned products, including EMA and national agency interactions.
• Communicate regulatory plans, risks and updates to leadership, affiliates and cross-functional stakeholders.
• Maintain awareness of evolving EU regulations and potential impact on product plans.

Connaissances

EU Regulatory Affairs

Cross-functional collaboration

Strategic thinking

Communication skills

Regulatory strategy

Formation

Life sciences or regulatory field degree

Outils

Regulatory databases

Description du poste

EU Regulatory Science Lead who is strategic, collaborative and adaptable to join our Global Regulatory Affairs team, based in our Brussels, Belgium offices.

About The Role

You will drive the EU regulatory strategy and activities for assigned products across development, approval and lifecycle activities. You will be the main regulatory contact for EU health authority interactions, including the EMA where relevant. You will help shape practical plans, identify regulatory risks, and work with global and regional partners to support timely submissions and informed decision‑making.

Who You Will Work With

You will work closely with the Global Regulatory Lead, EU affiliates, Global Regulatory Affairs colleagues, submission teams, and cross‑functional partners across development, clinical, medical, safety, quality and commercial teams. You will also collaborate with EU health authorities and contribute regional insight into global regulatory planning.

What You Will Do

• You will develop and implement EU regulatory strategies aligned with business objectives and global regulatory plans.
• You will be responsible for coordinating EU submission activities in line with regulations, guidelines, timelines and agreed strategies.
• You will manage EU regulatory risks by identifying options, recommending practical actions and supporting mitigation plans.
• You will act as the key EU contact for assigned products, including EMA and national agency interactions where needed.
• You will communicate clear regulatory plans, risks and updates to leadership, affiliates and cross‑functional stakeholders.
• You will maintain awareness of evolving EU regulations, guidelines, competitor activity and potential impact on product plans.

Qualifications

• You have a degree in life sciences, pharmacy, medicine, law or another relevant scientific or regulatory field.
• You bring strong experience in EU regulatory affairs, including product development, marketing authorisations and lifecycle management.
• You understand EU regulatory frameworks, procedures, health authority expectations and the evolving policy environment.
• You can translate complex regulatory information into clear recommendations for different audiences.
• You work well across functions, cultures and organisational boundaries, building alignment through evidence and credibility.
• You are curious and aware about digital tools, data science and AI, and their potential impact on regulatory science.
• You can adjust to changing conditions, learn quickly, and remain effective in evolving regulatory and scientific landscapes.
• You are self‑aware and looking for continuous learning and growth of self and others, by seeking and giving constructive feedback.

Equal Employment Opportunity Statement

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.