Regulatory Sciences Director

2 weeks ago

Uxbridge, United Kingdom Bristol Myers Squibb Full time

About the Role

Bristol Myers Squibb is seeking a highly skilled Associate Director to lead our global regulatory strategy for biomarkers, companion diagnostic tests, digital health, and other devices. As a key member of our team, you will be responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.

Key Responsibilities

  • Lead global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health, and other devices.
  • Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
  • Co-lead marketing application submission teams for indications at regulatory filing stage.
  • Ensure consistent positions are presented in responses to global Health Authority queries.
  • Develop global submission plans and Health Authority interaction plans in collaboration with the Global Regulatory sub-team.
  • Provide input into the development of protocol synopses and protocols.
  • Contribute to cross-functional rapid response teams to respond to Clinical Trial Application queries.

Requirements

  • Bachelor's degree required; advanced scientific degree preferred.
  • 5 years of industry experience with at least 4+ years of US Medical Device Regulatory Affairs experience.

Key Competencies

  • Experience in leading teams and representing regulatory functions on project teams.
  • Experience developing regulatory strategies in coordination with clinical plans and marketing objectives.
  • Experience with clinical trial assays and communicating between Diagnostic sponsor and Drug sponsor.
  • Ability to apply project management techniques and effectively manage meetings.
  • Demonstrated ability to breakdown complex scientific content and coordinate global activities.

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