Director of Regulatory Affairs

Regulatory Affairs Associate Director / Director – Companion Diagnostics (CDx) A well-funded clinical-stage biopharmaceutical company specializing in oncology therapeutics, including bi-specific/multi-specific antibodies and antibody-drug conjugates (ADCs), is seeking a Regulatory Affairs leader at the Associate Director or Director level. This role will lead IHC-based Companion Diagnostics (CDx) regulatory strategy and execution in support of an oncology ADC pipeline. Key Responsibilities Lead US regulatory strategy for IHC-based CDx programs across multiple oncology assets Serve as senior regulatory representative to FDA CDRH; lead Pre-Submission (Q-sub), IDE, and PMA interactions Build, mentor, and lead a growing CDx Regulatory Affairs team Partner with Drug Regulatory (CDER), Clinical Development, Biomarker, Pathology, and QA functions to ensure aligned drug-diagnostic co-development Coordinate with external diagnostic partners, CROs, and central laboratories Oversee IDE, PMA, and PMA supplement submissions; ensure analytical and clinical performance strategies meet FDA standards Identify and manage regulatory risks related to IHC assay performance, interpretation, and transfer Monitor evolving FDA CDx/IHC guidance and assess portfolio impact Qualifications Bachelor's degree or higher in Life Sciences, Pathology, Molecular Biology, or related field 8+ years (AD) or 10+ years (Director) of regulatory affairs experience in IVD/CDx Demonstrated experience leading FDA CDRH interactions for CDx programs Strong IHC-based CDx background including scoring systems and clinical cutoffs Proven cross-functional leadership and influence skills Preferred: oncology CDx, automated IHC platforms, team management, global CDx regulations (EU IVDR, NMPA) #J-18808-Ljbffr