Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
The Dir of Regulatory Affairs provides direct regulatory support for CDx. This role supports development & implementation of regulatory strategy for all CDx applications in both screening programs & early detection including IDE programs, IVD, & companion diagnostics. In this role you will support program efforts relative to premarket submissions, diagnostic partnering with biopharma, FDA interface regulatory policy & practice. Facilitate integration of Dx regulatory strategy at Guardant Health. This role, as an individual contributor, will report to the VP of Regulatory affairs & will liaise closely with the current regulatory & cross-functional teams at Guardant Health to bring innovative diagnostic assays to patients.
- Ensure early diagnostic regulatory input in early stages & during clinical development to Development Team for CDx.
- Oversee regulatory compliance & the action roadmap for activities with the FDA & EU & other regulatory bodies to ensure Guardant Health's interests are reflected.
- Collaborate closely with pharma partner regulatory affairs for all companion diagnostic programs.
- Provide input for all Business Development activities with respect to the regulatory risks & benefits of potential deals.
- Provide training for key stakeholders
- Represent the regulatory function with objective advocacy of the projects pipeline potential as well as the overall regulatory perspective in diagnostic regulatory requirements
- Ensure alignment of regulatory strategy to business strategy across all functional areas
- Manage development & negotiation of plans regarding safety, efficacy, & quality to assure viability for US & other global registrations.
- Accountable for ensuring that regulatory submissions meet appropriate standards & content requirements.
- Working with VP, Regulatory Affairs, identify risk areas & develop alternative courses of action including anticipation of regulators responses through scenario planning & development of contingency plans.
- Ensure compliance with the U.S.A FDA Code of Federal Regulations, the European in Vitro Diagnostic Directives, EN 13485 & other International Quality Standards as appropriate. This includes, but is not limited to, country specific licenses, the design input, review, out-put & verification, validation, transfer & change control.
- Provide updates as needed to the VP RA regarding regulatory status & requirements, both U.S. & European, of Company products. This includes the implementation of CE marking to products in accordance with IVDD 98/79/EEC.
- Compile and/or direct the compilation of device master records, technical files, design dossiers, FDA & European submission documents, and/or any other relate documents/reports, ensuring timely submissions to CDRH, etc., to meet Company product(s) & regulatory requirements, & compliance to all approved licenses.
- Responsibility for MDR reporting & assessments of adverse event reports to determine if reportable. Provide regulatory support as required in the evaluation of customer complaints, ensuring complaint reports meet regulatory requirements.
- Write & maintain procedures relating to the US & International Regulatory requirements.
- Champion the design, development & implementation & then support management, & maintenance of the Company's Quality System to meet the requirements of US FDA (21CFR 820 QSR, 21CFR 600 & 21 CFR 211), EN 13485, ISO 13485, IVDD & all other applicable quality & regulatory standards.
- Responsibility for ensuring Post Market surveillance/ vigilance systems, liaising with others in the quality departments, QA/QC.
- Complete other tasks as assigned by the VP, RA.
- Advanced education degree in life-sciences, engineering or public health with more than 5 years work related profession experience. Or a Bachelor's degree in similar fields with 8 plus years of experience.
- 3+ years experience in drug or diagnostic regulatory affairs.
- 5+ years multi/cross functional experience in regulatory and/or clinical development, preferably in molecular diagnostics
- Knowledge of IVDs or drug development & regulation affairs requirements
- Familiar with regulatory issues & challenges associated with Drug/Diagnostic co-development & companion diagnostics.
- Track record in successful FDA & ROW premarket submissions & registrations
- Solid understanding of molecular technologies & the impact on outcomes & diagnostic results
- Leadership capabilities working across varied cultures, expertise & backgrounds
- Excellent negotiation skills on various levels of hierarchy
- Outstanding interpersonal & communication skills for bridging scientific & business participants, for negotiating timelines & for effective collaboration.
All your information will be kept confidential according to EEO guidelines.