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Global Regulatory Sciences Director

1 month ago

Uxbridge, United Kingdom Bristol Myers Squibb Full time

Transforming Lives through Regulatory Excellence

Bristol Myers Squibb is a leader in the pharmaceutical industry, and we're seeking a talented Associate Director, Global Regulatory Sciences, Precision Medicine to join our team. In this role, you'll have the opportunity to work on cutting-edge projects that transform the lives of patients and drive innovation in the field of precision medicine.

Key Responsibilities

  • Develop and implement global regulatory strategies to support the development of biomarkers, companion diagnostic tests, and digital health devices.
  • Lead cross-functional teams to ensure regulatory compliance and develop global filing strategies.
  • Collaborate with global regulatory sub-teams to develop global submission plans and interact with health authorities.
  • Provide input into the development of protocol synopses and protocols, and contribute to cross-functional rapid response teams.
  • Contribute to the development of target labeling and ensure consistent positions are presented in responses to global health authority 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.
  • Experience in successfully leading teams, developing regulatory strategies, and communicating with governing bodies.

About Us

Bristol Myers Squibb is a global biopharmaceutical company that's dedicated to transforming patients' lives through science. We're a company that's passionate about making a difference, and we're looking for talented individuals like you to join our team.