Senior Regulatory Affairs Manager

Company Description

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Job Description

Senior Regulatory Affairs Manager – Oncology

Position Summary

The Senior Regulatory Affairs Manager will provide direct regulatory support for Oncology IVD/CDx products (Guardant360 CDx and future products such as Tissue IVD/CDx) in all stages of the product lifecycle. This role will actively lead and support development and implementation of regulatory strategies, premarket submissions, post-market submissions, labeling review, interactions with regulatory bodies, and other related regulatory activities, primarily for the US market. Responsibilities will include all aspects of product core team regulatory support, including planning, regulatory strategy, technical document review, preparation of submissions, and interpretation of regulations and requirements.

This position is an individual contributor role with expectations to be hands-on and will report to the Sr. Director of Regulatory Affairs – Oncology and will liaise closely with regulatory and cross-functional teams at Guardant Health, to bring innovative cancer screening assays to market and keep them compliant.

Position level/title will depend on experience.

Essential Duties and Responsibilities

• Effectively prepare and manage FDA submissions including pre-market (PMAs, Q-Subs, IDEs, BDDs, SIRs) and post-market (sPMAs, 30-Day notices, Annual Reports) regulatory submissions in adherence with applicable regulations for submission to government agencies.
• Represent regulatory affairs in cross-functional project teams to support both new product development and on-market product support efforts.
• Actively review project and submission related documentation including analytical, clinical, V&V, risk, quality, labeling, and manufacturing.
• Support regulatory activities throughout product lifecycle and maintain registrations by ensuring regulatory compliance.
• Facilitate product approvals through effective communications and negotiations with regulatory agencies and project teams.
• Support the planning and execution of the regulatory strategic direction for the business.
• Responsible for managing regulatory workflow, including prioritizing project deliverables and establishing timeframes, for projects with cross-functional teams.
• Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
• Lead and coordinate internal tracking, authoring, and review of responses to requests from regulatory agencies.
• Identify project risk and develop alternate strategies or contingency plans as mitigation.
• Provide strategic advice to the cross-functional team in response to their queries, based on regulatory experience and area of expertise.
• Build and maintain a cooperative and respectful working environment. Be available as an internal resource for peers, advising on regulatory issues and strategies.
• Provide updates to project teams and management regarding regulatory status and requirements of company products.

Qualifications