Director, Early Precision Medicine Regulatory Affairs

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.

Requirements

• Solid scientific background, PhD., M.D., PharmD, MS
• Significant experience in regulatory affairs and diagnostic-related development e.g., >8-10 years.
• Scientific & Diagnostic Expertise: Deep expertise in global diagnostic development—including, but not limited to key markets such as US, EU, Canada, Australia, Japan, China submissions, etc.—with preferred subject matter proficiency in IHC, NGS, PCR, and/or mass spectrometry, spanning assay design through regulatory approval.
• Biomarker & CDx Strategy: Extensive experience in designing regulatory strategies for companion diagnostics and biomarkers, with deep expertise in assay and IVD development—including analytical validation, clinical development, manufacturing, and global regulatory submissions through commercialization.
• Regulatory Leadership & Strategic Planning: Proven ability to lead teams through complex health authority interactions and issue resolution, paired with deep expertise in developing and executing global regulatory strategies across drug and device development.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.