Senior Regulatory Affairs Manager

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

The Senior Manager, Regulatory Affairs will serve as a regulatory lead to support and execute global regulatory strategies for registration and compliance of assigned products.  The individual will support program efforts relative to regulatory activities and serve as a subject matter expert to cross-functional teams.  Responsibilities may include all aspects of planning and implementation of global regulatory filings, including preparation of submissions, reviewing protocols and reports, and interpreting regulations and guidelines. 

This position will report to the Associate Director of Regulatory Affairs and will liaise closely with Regulatory Affairs and cross-functional teams at Guardant Health to bring innovative diagnostic assays to patients.

Essential Duties and Responsibilities

• Responsible for managing and supporting regulatory strategy and project workflow including prioritizing deliverables and establishing and maintaining project timelines.
• Effectively prepare regulatory submission documents in adherence with applicable regulations, directives, guidelines and/or standards.
• Facilitate product approvals and registrations through effective communications and negotiations. Lead and coordinate tracking, authoring, and review of responses to requests from health authorities.
• Manage development and negotiation of plans regarding safety, effectiveness, and quality to ensure compliance and viability for global product registrations.
• Identify risk areas and potential solutions through scenario planning and development of contingency plans.
• Collaborate closely with different functions (e.g., Program Management, Product Development, Quality, Operations, and external partners) and participate in project teams to ensure alignment of regulatory strategy and provide input on risks and benefits of potential plans.
• Support regulatory activities throughout product lifecycle and ensure registrations are maintained. Provide regulatory input, as required, in the evaluation of complaints, regulatory reporting requirements, use scenarios (RUO, IUO/PEO, IVD), quality system requirements, audits and inspections, postmarket surveillance, and other areas.
• Author, review and/or maintain procedures relating to global regulatory requirements and processes and company policies.
• Provide updates, as needed, to project teams and management regarding regulatory status and requirements of Company products.

Qualifications

• Advanced education degree in life sciences, engineering, law or public health with at least 6 years work-related professional experience. Or a Bachelor’s degree in similar fields with at least 8 years of experience.
• 5+ years multi/cross functional experience in regulatory and/or clinical development, preferably in molecular diagnostics
• Knowledge of ex-US IVD or medical device development and regulatory affairs requirements
• Familiar with regulatory issues and challenges associated with diagnostic and medical device development, which may include drug/diagnostic co-development and companion diagnostics
• Solid knowledge of molecular technologies and IVD/medical device development process, including quality, compliance and life cycle management aspects
• Successful track record of supporting and maintaining product approvals and registrations through effectively preparing and coordinating global regulatory submissions
• Strong capabilities working across varied functions, cultures and backgrounds
• Innovative strategic planning and strong analytical skills
• Excellent communication skills (verbal and written) and ability to convey complex issues in a straightforward manner
• Highly organized and able to balance multiple projects effectively

Additional Information

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be req