Associate Director / Director, Regulatory Affairs – IHC Companion Diagnosti at Systimmune

Redmond, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

03 May, 26

Salary

0.0

Posted On

02 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Companion Diagnostics, FDA Engagement, IHC Development, Team Leadership, Cross-Functional Collaboration, Risk Management, Clinical Performance, Regulatory Strategy, Mentorship, Oncology, Submission Oversight, Analytical Performance, Governance, Communication, Decision-Making

Industry

Biotechnology Research

Description

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 sufficiently 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. Key Responsibilities 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 Qualifications 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) Leadership Competencies Strategic decision-making with execution awareness Clear, confident FDA-facing communication Ability to develop people and build scalable regulatory functions Strong judgment balancing regulatory rigor with program timelines

Responsibilities

The role involves leading the regulatory strategy for IHC-based Companion Diagnostics and serving as the regulatory authority for CDx programs. The successful candidate will guide cross-functional teams and ensure high-quality submissions to the FDA.