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Regulatory Jobs in Bothell, WA (NOW HIRING)

Lyell Immunopharma

Director, Regulatory Affairs

Seattle, WA · On-site

$210K - $260K/yr

The Director of Regulatory Affairs/Global Regulatory Lead (GRL) will be focusing on the development of cutting-edge CAR-T cell therapies in oncology. As the GRL, you will define, develop, and execute ...

Lyell Immunopharma

Director, Regulatory Affairs

Seattle, WA · On-site

$210K - $260K/yr

The Director of Regulatory Affairs/Global Regulatory Lead (GRL) will be focusing on the development of cutting-edge CAR-T cell therapies in oncology. As the GRL, you will define, develop, and execute ...

YO AI Labs

Regulatory Affairs Expert - Remote

Seattle, WA · Remote

$50 - $80/hr

Regulatory Affairs Specialist Location: Remote Job Type: Contract We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating ...

YO AI Labs

Regulatory Affairs Expert - Remote

Seattle, WA · Remote

$50 - $80/hr

Regulatory Affairs Specialist Location: Remote Job Type: Contract We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating ...

Uw

Regulatory Affairs Operations Manager

Seattle, WA · On-site

$174K/yr

Ensures all regulatory & accrediting body program objectives and requirements are achieved. * Proactively leads hospital-wide preparation for regulatory body surveys and investigations, ensuring ...

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Regulatory information

See Bothell, WA salary details

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How much do regulatory jobs pay per hour?

As of Sep 6, 2026, the average hourly pay for regulatory in Bothell, WA is $44.98, according to ZipRecruiter salary data. Most workers in this role earn between $36.06 and $53.27 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in a regulatory role, and why are they important?

To thrive in a Regulatory role, you need a strong understanding of compliance frameworks, regulatory guidelines, and industry standards, often supported by a degree in law, life sciences, or a related field. Familiarity with regulatory submission systems, document management tools, and certifications such as RAC (Regulatory Affairs Certification) are advantageous. Attention to detail, analytical thinking, and effective communication are critical soft skills for managing regulatory processes and liaising with authorities. These abilities ensure timely approvals, minimize compliance risks, and support organizational reputation and market access.

What are some common challenges faced in a regulatory role, and how can they be addressed?

Professionals in Regulatory roles often face the challenge of keeping up with constantly evolving laws and industry standards. Staying current requires ongoing education, close collaboration with legal teams, and proactive monitoring of regulatory updates. Additionally, balancing compliance requirements with business goals can be complex, so strong communication and problem-solving skills are essential. Building relationships with internal departments and regulatory agencies can help streamline processes and ensure timely responses to regulatory changes.

What is the difference between Regulatory vs Compliance Officer?

AspectRegulatoryCompliance Officer
Required CredentialsRegulatory certifications, industry-specific licensesCompliance certifications, such as CCEP or CRCM
Work EnvironmentRegulatory agencies, government bodies, legal teamsCorporate offices, compliance departments, financial institutions
Employer & Industry UsageUsed in industries like healthcare, finance, manufacturingCommon in banking, insurance, healthcare sectors
Search & Comparison IntentUnderstanding regulatory roles, legal complianceEnsuring company adherence to policies, internal audits

While both roles focus on adherence to rules, Regulatory professionals primarily interpret and implement government regulations, often working with legal and government entities. Compliance Officers focus on internal policies and procedures to ensure their organization meets legal and ethical standards. Both roles are essential for risk management but differ in scope and focus.

What is a regulatory job?

A regulatory job involves ensuring that organizations comply with laws, regulations, and standards relevant to their industry. Professionals in this field often review policies, prepare documentation, and work with government agencies to maintain compliance, requiring knowledge of legal requirements and attention to detail.

What are popular job titles related to Regulatory jobs in Bothell, WA?

For Regulatory jobs in Bothell, WA, the most frequently searched job titles are:

What job categories do people searching Regulatory jobs in Bothell, WA look for?

The top searched job categories for Regulatory jobs in Bothell, WA are:

What cities near Bothell, WA are hiring for Regulatory jobs?

Cities near Bothell, WA with the most Regulatory job openings:

Regulatory jobs near you
Infographic showing various Regulatory job openings in Bothell, WA as of August 2026, with employment types broken down into 1% As Needed, 91% Full Time, 6% Part Time, and 2% Contract. Highlights an 86% Physical, 3% Hybrid, and 11% Remote job distribution, with an average salary of $93,562 per year, or $45 per hour.

Director, Regulatory Affairs

Lyell Immunopharma

Seattle, WA • On-site

$210K - $260K/yr

Full-time

Posted 16 days ago

Job description

Using living cells to treat - and sometimes even cure - cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell's product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.
This role can be based out of either our Seattle, WA or South San Francisco, CA offices.
The Director of Regulatory Affairs/Global Regulatory Lead (GRL) will be focusing on the development of cutting-edge CAR-T cell therapies in oncology.
As the GRL, you will define, develop, and execute the global regulatory strategy for assigned CAR-T programs from early clinical development through licensure (BLA/MAA) and lifecycle management. You will serve as the primary regulatory representative to global health authorities (FDA, EMA, etc.), ensuring alignment with business objectives and driving innovative approaches to accelerate the development of transformative therapies for patients.
KEY ROLE AND RESPONSIBILITIES:
Global Regulatory Strategy & Leadership
  • Develop & Execute Strategy: Create and lead comprehensive, creative, and innovative global regulatory strategies to support the development and commercialization of CAR-T cell therapy products.
  • Represent Regulatory: Represent the Regulatory Team in cross-functional meetings, ensuring alignment with regional regulatory requirements, CMC, and clinical development plans.
  • Risk Mitigation: Proactively identify regulatory risks, develop contingency plans, and anticipate hurdles in the evolving CAR-T regulatory landscape.
  • Drive Milestones: Accountable for timely submission and approval of global regulatory dossiers (IND, CTA, BLA, MAA).

Health Authority Interactions
  • Primary Liaison: Act as the primary point of contact and lead negotiations with regulatory agencies (FDA, EMA, etc.), including managing FDA meetings (Pre-IND, EOP2, Pre-BLA) and briefing document preparation.
  • Agency Negotiation: Support regional teams in resolving key regulatory issues to expedite clinical study country expansion.

Cross-Functional Collaboration
  • Strategic Input: Partner with CMC, Clinical Development, Translational Medicine, and Medical Affairs teams to align regulatory strategy with scientific breakthroughs and market access goals.
  • Content Review: Review and approve key regulatory documents, including clinical protocols, investigator brochures, and non-clinical reports.
  • Mentor Staff: Provide coaching and mentoring to junior regulatory staff and other RA team members.

Regulatory Intelligence
  • Stay Current: Monitor and analyze emerging regulations, guidelines, and competitor intelligence in the cell and gene therapy field.
PREFERRED EDUCATION:
Bachelor's degree in Life Sciences required. Advanced degree (PhD, PharmD, or MD) is strongly preferred.
PREFERRED EXPERIENCE:
Experience: A minimum of 15+ years in the biopharmaceutical industry, with at least 8 years of direct Regulatory Affairs experience.
Modalities: Substantial experience in cell and gene therapy, specifically with CAR-T or T-cell engaging modalities.
Submissions: Proven track record of leading major submissions (IND/CTA) and experience in BLA/MAA preparation.
HA Interactions: Proven ability to interact effectively and negotiate with regulatory authorities.
Desired Skills:
  • Deep understanding of FDA regulations for Advanced Therapy Medicinal Products (ATMPs).
  • Strong strategic thinking and ability to balance short-term needs with long-term vision.
  • Exceptional communication and negotiation skills.
  • Proven ability to work in a complex, matrixed, and fast-paced environment

The salary range for this position is $210,000 to $260,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell's compensation practices and an applicant's qualifications and experience. Employees are also eligible to participate in Lyell's Equity Incentive Plan.
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

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