AD​/Director, Regulatory Affairs

Associate Director / Director, Regulatory Affairs – Companion Diagnostics

Location: Hybrid in Seattle, WA or Princeton, NJ

Compensation: $150,000 – $230,000 base salary, depending on experience

We are seeking an experienced Regulatory Affairs leader to support our client, an IHC-based Companion Diagnostic (CDx) programs within an oncology ADC pipeline. This role will lead CDx regulatory strategy and execution, including FDA CDRH engagement, IDE and PMA submissions, and regulatory oversight across multiple oncology programs.

The ideal candidate will have strong experience in IVD/CDx regulatory affairs, hands‑on knowledge of IHC-based companion diagnostics, and the ability to lead cross‑functional teams. This is a leadership role with the opportunity to help build and mentor a growing CDx Regulatory Affairs team over time.

• Lead U.S. regulatory strategy for IHC-based Companion Diagnostics across oncology programs
• Serve as the regulatory lead for CDx development, submissions, and FDA CDRH interactions
• Lead FDA Pre‑Submission, IDE, PMA, and PMA supplement activities
• Prepare and review FDA briefing packages, responses, and regulatory documentation
• Partner closely with Drug Regulatory, Clinical Development, Biomarker, Pathology, QA, external diagnostic partners, CROs, and central labs
• Provide regulatory guidance on IHC assay performance, scoring systems, cutoff rationale, and clinical validation strategies
• Identify and manage regulatory risks related to assay development, interpretation, transfer, and submission timelines
• Support inspection readiness and ensure regulatory compliance across internal and external partners
• Help establish CDx regulatory processes, best practices, and governance
• Build, mentor, and lead a CDx Regulatory Affairs team as the function grows

• Bachelor’s degree or higher in Life Sciences, Pathology, Molecular Biology, or a related field
• 8+ years of regulatory affairs experience for Associate Director level, or 10+ years for Director level
• Strong experience in IVD and/or Companion Diagnostics regulatory affairs
• Demonstrated experience leading FDA CDRH interactions for CDx programs
• Hands‑on knowledge of IHC‑based CDx development, including scoring systems and clinical cutoff strategies
• Experience supporting IDE, PMA, or PMA supplement submissions
• Ability to lead cross‑functional teams and influence stakeholders across drug and diagnostic development

• Prior experience managing or building regulatory teams
• Oncology CDx experience, particularly supporting patient selection strategies
• Experience with automated IHC platforms
• Experience working with external diagnostic partners, CROs, or central laboratories
• Familiarity with global CDx regulations, including EU IVDR and China NMPA

• Strategic regulatory leader who can also stay close to execution
• Confident and clear in FDA‑facing communication
• Strong collaborator across clinical, biomarker, pathology, QA, and regulatory teams
• Able to balance regulatory rigor with program timelines
• Comfortable building scalable processes and mentoring junior team members

The role offers a comprehensive benefits package, including medical, dental, and vision coverage, short‑ and long‑term disability, 401(k) match, PTO, sick leave, paid holidays, and additional benefits.

Candidates must be able to commit to a hybrid schedule in either Seattle, WA or Princeton, NJ.