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Regulatory Sciences Director

2 months 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

  • Develop and implement global regulatory strategies to support the development of biomarkers, companion diagnostic tests, and digital health devices.
  • Lead marketing application submission teams for indications at the regulatory filing stage, developing content strategy for global dossiers.
  • Ensure consistent positions are presented in responses to global Health Authority queries.
  • Collaborate with the Global Regulatory sub-team to develop global submission plans and Health Authority interaction plans.
  • Provide input into the development of protocol synopses and protocols, contributing to cross-functional rapid response teams to respond to Clinical Trial Application queries.
  • Contribute to the development of target labeling.

Requirements

  • Bachelor's degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry and at least 4+ years of US Medical Device Regulatory Affairs experience.
  • Experience in successfully leading teams, utilizing leadership techniques to drive team development.
  • Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
  • Experience with clinical trial assays (CTA) in drug clinical trials, communicating between Diagnostic sponsor and Drug sponsor.
  • Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry.
  • Ability to apply project management techniques within teams and effectively manage meetings.
  • Demonstrated ability to breakdown complex, scientific content into logical components.
  • Ability to coordinate global activities, facilitate issue resolution, and conflict management.
  • Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks.
  • Demonstrated ability to negotiate with and influence others.
  • Understanding of strategic and tactical role for the drug development process.
  • Understanding of general global regulatory requirements for drugs in development.