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Associate Director, Regulatory Affairs (REMOTE, HY

Company: Guardant Health
Location: Palo Alto
Posted on: May 16, 2022

Job Description:

Job DescriptionCompany Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood 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 launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.Job Description

(We are open to Remote, Hybrid, and/or On-site options)The Associate Director, Regulatory Affairs will serve as a regulatory lead to develop and execute global regulatory strategies for registration and compliance of assigned products. The individual will support program efforts relative to regulatory activities and provide expert advice and recommendations 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 is a management, business and expert role.This position will report to the Vice President of Regulatory Affairs and will liaise closely with regulatory and cross-functional teams at Guardant Health to bring innovative diagnostic assays to patients.Essential Duties and Responsibilities

  • Responsible for leading and managing regulatory strategy and project workflow including prioritizing deliverables and establishing and maintaining project timelines for submissions.
  • Effectively prepare regulatory submission documents in adherence with applicable regulations, directives, guidelines and/or standards for submissions to global health authorities.
  • Facilitate product approvals and registrations through effective communications and negotiations with health authorities. Lead and coordinate internal tracking, authoring, and review of responses to requests from health authorities.
  • Manage development and negotiation of plans regarding safety, effectiveness, and quality to assure viability for global registrations.
  • Identify risk areas and potential solutions through scenario planning and the development of contingency plans.
  • Participate in the planning and execution of the regulatory strategic direction for the business in assigned areas.
  • Collaborate closely with other functions (e.g., program management, product development, quality, operations, and external partners) to ensure alignment of regulatory strategy, drive regulatory activities, and provide input on regulatory risks and benefits of potential development strategies.
  • Author, review and/or maintain procedures relating to global regulatory requirements (such as IVDR) and processes and company policies.
  • Oversee regulatory activities throughout product lifecycle and maintain registrations by ensuring regulatory compliance. Provide regulatory input, as required, in the evaluation of complaints, reporting requirements, use scenarios (RUO, IUO/PEO, IVD), quality system requirements, audits and inspections, postmarket surveillance, and other areas.
  • Provide training for key stakeholders.
  • 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 8 years work-related professional experience. Or a Bachelor's degree in similar fields with at least 10 years of experience.
    • 5+ years multi/cross-functional experience in regulatory and/or clinical development, preferably in molecular diagnostics
    • Knowledge of IVD or medical device development and regulatory affairs requirements
    • Familiarity with regulatory issues and challenges associated with diagnostic and medical device development, which may include drug/diagnostic co-development and companion diagnostics
    • Demonstrated experience preparing technical documentation for global regulatory submissions. Experience with registrations in the European Union is a plus.
    • Successful track record of securing and maintaining product approvals and registrations through application of strong communication and analytical skills
    • Prior experience interacting with a major regulatory agency is preferred
    • Solid understanding of molecular technologies and IVD/medical device development process, including quality, compliance and lifecycle management
    • Leadership 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
    • Strong organizational skills to balance activities for multiple projects

      Additional Information

      Covid Vaccination Policy: Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant's COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws. An employee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters.Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.All your information will be kept confidential according to EEO guidelines.

      To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.Please visit our career page at: http://www.guardanthealth.com/jobs/#LI-JL1, #LI-ONSITE #LI-HYBRID, #LI-REMOTE

Keywords: Guardant Health, Palo Alto , Associate Director, Regulatory Affairs (REMOTE, HY, Executive , Palo Alto, California

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