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Global Regulatory Affairs Leader

2 months ago

Slough, Slough, United Kingdom UCB Full time
About the Role

The Global Regulatory Affairs Leader provides strategic leadership to assigned projects, overseeing the development and implementation of global regulatory strategies and plans. This role is accountable for ensuring timely product milestones, including health authority meetings, new indications, and approval with a viable label.

Key Responsibilities
  • Develop and implement global regulatory strategies and plans to meet business objectives and patient needs.
  • Provide regulatory leadership to assigned projects, ensuring timely delivery of regulatory milestones.
  • Collaborate with cross-functional teams to identify and mitigate regulatory risks.
  • Develop and maintain relationships with health authorities and regulatory stakeholders.
  • Ensure global alignment of key messages and submission documents.
  • Identify and implement process improvements to enhance regulatory efficiency.
Requirements
  • Bachelor's degree in a relevant field.
  • Several years' experience in pharmaceutical regulatory affairs.
  • Knowledge of global regulatory procedures and legislation.
  • Global and integrated cross-functional view into pharmaceutical project management and drug development/approval and commercialization.
  • Good track record of delivering regulatory approvals.
About UCB

UCB is a global biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies for patients with severe diseases. We are committed to making a difference in the lives of patients and their families.