SystImmune · 1 day ago
Associate Director / Director, Regulatory Affairs – IHC Companion Diagnostics (CDx)
Redmond, WA
Full-time
Onsite
Lead/Staff, Director/Executive
$150K/yr - $230K/yr
8+ years expSystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments. They are seeking a Regulatory Affairs leader to lead IHC-based Companion Diagnostics regulatory strategy and execution for their oncology ADC pipeline, ensuring high-quality submissions and building a growing regulatory team.
BiopharmaBiotechnologyProfessional Services
Responsibilities
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
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
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
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
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
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
Qualification
Required
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
Preferred
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)
Benefits
100% paid employee premiums for medical/dental/vision
STD
LTD
401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years
15 PTO days per year
Sick leave
11 paid holidays
Company
SystImmune
SystImmune is a biotechnology company.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Martin S. Olivo, MD, MSc,
Chief Medical Officer
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