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Fda Director Salary Jobs in Bothell, WA (NOW HIRING)

Lyell Immunopharma

Director, Regulatory Affairs

Seattle, WA · On-site

$210K - $260K/yr

You will serve as the primary regulatory representative to global health authorities (FDA, EMA, etc ... The salary range is an estimate, and the actual salary may vary based on Lyell's compensation ...

Lyell Immunopharma

Director, Regulatory Affairs

Seattle, WA · On-site

$210K - $260K/yr

You will serve as the primary regulatory representative to global health authorities (FDA, EMA, etc ... The salary range is an estimate, and the actual salary may vary based on Lyell's compensation ...

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All JobsFda Salary JobsFda Director Salary JobsFda Director Salary Jobs in Bothell, WA

Fda Director Salary information

What is the difference between Fda Director Salary vs Fda Manager Salary?

AspectFda Director SalaryFda Manager Salary
Required CredentialsBachelor's degree, advanced certifications often preferredBachelor's degree, relevant certifications
Work EnvironmentExecutive leadership in regulatory agencies or pharmaceutical companiesMid-level management in regulatory or quality departments
Employer & IndustryFederal agencies, biotech, pharmaceutical industriesPharmaceutical companies, biotech firms, regulatory consulting
Salary RangeTypically higher, often six-figure salariesModerate to high five-figure salaries

The Fda Director generally earns a higher salary than the Fda Manager due to greater responsibilities, leadership roles, and required experience. While both roles work within regulatory environments, directors oversee strategic initiatives, whereas managers focus on operational tasks.

What job categories do people searching Fda Director Salary jobs in Bothell, WA look for?

The top searched job categories for Fda Director Salary jobs in Bothell, WA are:

Fda Director Salary jobs near you
Infographic showing various Fda Director Salary job openings in Bothell, WA as of August 2026, with employment types broken down into 85% Full Time, 12% Part Time, and 3% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution.

Associate Director / Director, Regulatory Affairs - IHC Companion Diagnostics (CDx)

SystImmune, Inc

Redmond, WA • On-site

$150K - $230K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 2 days ago

Job description

SystImmune 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 established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. 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 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
  • 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

Compensation and Benefits:
The expected base salary range for this position is $150,000 - $230,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 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, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

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