Director, Early Precision Medicine Regulatory Affairs

Bristol Myers Squibb
Madison, NJ
Category Healthcare
Job Description
Bristol Myers Squibb is seeking a Director of Early Precision Medicine Regulatory Affairs to lead global regulatory strategy for biomarkers and diagnostics. This role focuses on supporting registrations and establishing scalable frameworks for research development, ensuring timely and compliant submissions. The director will collaborate with regulatory, clinical, and market teams to accelerate access to precision therapies. It requires a strong scientific and regulatory background with expertise in key therapeutic areas like IHC, NGS, PCR, and mass spectrometry.

Requirements

  • Solid scientific background, PhD., M.D., PharmD, MS
  • Significant experience in regulatory affairs and diagnostic-related development (8-10 years)
  • Proven ability to lead teams through health authority interactions
  • Deep expertise in assay and IVD development
  • Experience with GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11, 312, 812, 820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, and ICH guidelines

Benefits

  • Medical, pharmacy, dental and vision care
  • Wellbeing support
  • Financial well-being resources
  • 401(K)
  • Parental, caregiver, bereavement, and military leave
  • Family care services
  • Tuition reimbursement
  • Recognition program
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