Director, Early Precision Medicine Regulatory Affairs

Bristol Myers Squibb

Princeton, NJ, US
Princeton - nj - us: $217,960 - $264,113; san dieg...
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Global regulatory strategy for biomarkers
Early-stage development through proof of concept
Investigational assay development frameworks
** Bristol Myers Squibb is seeking a Director of Early Precision Medicine Regulatory Affairs to lead global regulatory strategy for biomarkers and diagnostics in early-stage development. The ideal candidate will possess significant regulatory experience, a strong scientific background, and the ability to drive innovative regulatory strategies within a collaborative environment. **

Job Summary

  • The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and diagnostics, focusing on early-stage development through proof of concept and supporting registrations.
  • This role establishes scalable frameworks for investigational assay development, ensuring timely, compliant submissions that support patient stratification in Phase I/II studies.
  • As a key member of the Translational Medicine CLIA Laboratory Steering Committee, the director drives coordinated early-stage drug-diagnostic strategies and health authority engagement to accelerate access to precision therapies.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Director of Early Precision Medicine Regulatory Affairs to lead global regulatory strategy for biomarkers and diagnostics in early-stage development. The ideal candidate will possess significant regulatory experience, a strong scientific background, and the ability to drive innovative regulatory strategies within a collaborative environment. **

Salary

Princeton - NJ - US: $217,960 - $264,113; San Diego - CA - US: $240,460 - $291,377; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • Global regulatory strategy for biomarkers
  • Early-stage development through proof of concept
  • Investigational assay development frameworks
  • Drug-diagnostic strategies
  • Health authority engagement
  • Precision medicine regulatory expertise

Nice-to-have

  • Innovation in early precision medicine
  • Cross-functional leadership
  • Translational Medicine CLIA Laboratory Steering Committee
  • High-impact collaboration
  • Strategic regulatory thought leader

Key Requirements

  • >8-10 years in regulatory affairs and diagnostic-related development
  • PhD., M.D., PharmD, or MS degree
  • Deep expertise in global diagnostic development (US, EU, Canada, Australia, Japan, China)
  • Extensive experience in designing regulatory strategies for companion diagnostics and biomarkers
  • Proven ability to lead teams through complex health authority interactions
  • Mastery of regulatory standards (GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11, 312, 812, 820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, ICH)

Work Rights

Not specified

Tailored Resume

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