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UCB Pharma

Biopharmaceuticals for neurology and immunology therapies

EU Regulatory Science Lead

Regulatory & Quality (Life Sciences)Posted on Nov 12
Full-timeBrussels, BelgiumNo salary listed

About the Job

Requirements

  • A degree in life sciences, pharmacy, medicine, law, or another relevant scientific or regulatory field.
  • Strong experience in EU regulatory affairs, including product development, marketing authorisations, and lifecycle management.
  • Understanding of EU regulatory frameworks, procedures, health authority expectations, and the evolving policy environment.
  • Ability to translate complex regulatory information into clear recommendations for different audiences.
  • Ability to work across functions, cultures, and organisational boundaries, building alignment through evidence and credibility.
  • Awareness of digital tools, data science, and artificial intelligence, and their potential impact on regulatory science.
  • Ability to adjust to changing conditions, learn quickly, and remain effective in evolving regulatory and scientific landscapes.
  • Commitment to continuous learning and growth of self and others, including seeking and giving constructive feedback.

Responsibilities

  • Develop and implement EU regulatory strategies aligned with business objectives and global regulatory plans.
  • Coordinate EU submission activities in line with regulations, guidelines, timelines, and agreed strategies.
  • Identify EU regulatory risks, recommend practical actions, and support mitigation plans.
  • Act as the key EU contact for assigned products, including interactions with the European Medicines Agency and national agencies where needed.
  • Communicate regulatory plans, risks, and updates to leadership, affiliates, and cross-functional stakeholders.
  • Maintain awareness of evolving EU regulations, guidelines, competitor activity, and potential impacts on product plans.

About the Company

UCB Pharma

Biopharmaceuticals for neurology and immunology therapies

UCB Pharma focuses on developing treatments for severe diseases in neurology and immunology. It discovers, develops, and commercializes novel molecules and generates products aimed at improving patient lives. The company works by researching and developing therapies, integrating patient insights to guide innovation, and investing over a quarter of revenue into scientific research. Its global presence (about 9,000 employees across 40 countries) and €5.3 billion 2023 revenue reflect its scale and commitment to bringing therapies to patients worldwide. UCB differentiates itself by combining direct patient engagement with substantial R&D investment to address unmet needs in neurology and immunology, aiming to transform lives through science and patient care.

Company size
10,001+
Company stage
IPO
Headquarters
City of Brussels, Belgium
Founded
1928

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