EU Regulatory Strategy 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

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.