Associate Director​/Director, Regulatory Affairs – IHC Companion Diagnostics; CDx

Overview

Syst Immune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its platforms for bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). Syst Immune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications, and a robust preclinical pipeline in discovery and IND-enabling stages.

We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

We are seeking a Regulatory Affairs leader at the Associate Director or Director level to lead IHC-based Companion Diagnostics (CDx) regulatory strategy and execution in support of our oncology ADC pipeline. This role will serve as the regulatory authority for CDx programs, with direct FDA CDRH engagement, and will build and lead a growing CDx Regulatory team over time. The successful candidate will set regulatory direction, guide cross-functional teams, and ensure high-quality IDE and PMA submissions, while remaining hands-on to provide technical oversight and mentorship when needed.

This position reports directly to the Head of CDx and is a core leadership role in the CDx organization.

• CDx Regulatory Leadership
  • Lead US regulatory strategy for IHC-based Companion Diagnostics across multiple oncology programs
  • Serve as the regulatory decision-maker for CDx development, submissions, and FDA engagement
  • Establish CDx regulatory best practices, processes, and governance within the organization
• FDA CDRH Engagement & Representation
  • Act as the senior regulatory representative to FDA CDRH for IHC CDx programs
  • Lead FDA Pre-Submission (Q-sub), IDE, and PMA interactions at a strategic and executional level
  • Guide preparation of FDA briefing packages and responses, ensuring scientific and regulatory consistency
• Team Building & People Leadership
  • Build, mentor, and lead a CDx Regulatory Affairs team, with direct reports added over time
  • Set expectations, review work quality, and develop regulatory talent within the CDx organization
  • Provide regulatory leadership and mentorship to cross-functional partners and junior team members
• Cross-Functional & External Leadership
  • Partner with Drug Regulatory (CDER), Clinical Development, Biomarker, Pathology, and QA leaders to ensure aligned drug–diagnostic co-development
  • Lead regulatory coordination with external diagnostic partners, CROs, and central laboratories
  • Represent CDx Regulatory perspectives in senior cross-functional and program governance meetings
• Submission Oversight & Quality
  • Provide leadership oversight for IDE, PMA, and PMA supplement submissions for IHC CDx
  • Ensure analytical and clinical performance strategies (including scoring and cutoff rationale) meet FDA expectations
  • Maintain high regulatory quality standards while enabling efficient execution
• Risk Management & Readiness
  • Identify and proactively manage regulatory risks related to IHC assay performance, interpretation, and transfer
  • Support inspection readiness and regulatory compliance for CDx partners and internal processes
  • Monitor evolving FDA CDx and IHC-related guidance and assess impact on portfolio strategy

• Bachelor’s degree or higher in Life Sciences, Pathology, Molecular Biology, or related field
• 8+ years (Associate Director) or 10+ years (Director) of regulatory affairs experience in IVD/CDx
• Demonstrated experience leading FDA CDRH interactions for Companion Diagnostics
• Strong background in IHC-based CDx development, including understanding of scoring systems and clinical cutoffs
• Proven ability to lead cross-functional teams and influence without authority

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

• Strategic decision-making with execution awareness
• Clear, confident FDA-facing communication
• Ability to develop people and build scalable regulatory functions
• Strong…