Senior Regulatory Affairs Manager Oncology
Offer summary
Qualifications:
Bachelor’s degree in Life Sciences, Engineering, or related field., At least 7 years of relevant regulatory affairs experience in IVD or molecular diagnostics., Proven success in authoring and leading FDA regulatory submissions., Strong knowledge of IVD/CDx development processes and regulatory requirements..Key responsibilities:
- Prepare and manage FDA submissions for pre-market and post-market activities.
- Support regulatory strategies and interactions with regulatory agencies.
- Review technical documentation and ensure regulatory compliance throughout product lifecycle.
- Collaborate with cross-functional teams to bring cancer screening assays to market.
Job description
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, realworld data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in earlystage 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 DescriptionSenior Regulatory Affairs Manager – Oncology
Position Summary
The Senior Regulatory Affairs Manager Oncology will provide direct regulatory support for Oncology IVDCDx products (Guardant360 CDx and future products such as Tissue IVDCDx) in all stages of the product lifecycle. This role will actively lead and support development and implementation of regulatory strategies, premarket submissions, postmarket 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 handson and will report to the Sr. Director of Regulatory Affairs – Oncology and will liaise closely with regulatory and crossfunctional teams at Guardant Health, to bring innovative cancer screening assays to market and keep them compliant.
Essential Duties and Responsibilities
- Effectively prepare and manage FDA submissions including premarket (PMAs, QSubs, IDEs, BDDs, SIRs) and postmarket (sPMAs, 30Day notices, Annual Reports) regulatory submissions in adherence with applicable regulations for submission to government agencies.
- Represent regulatory affairs in crossfunctional project teams to support both new product development and onmarket 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 crossfunctional 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 crossfunctional 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.
QualificationsQualifications
- Bachelor’s degree in Life Sciences, Engineering, or related discipline with at least 7 years of relevant regulatory affairs experience in an IVD regulatory affairs role, preferably in molecular diagnostics or closely related area; OR an advanced degree with at least 5 years of relevant experience in an IVDCDx regulatory affairs role. Alternatively, at least 3 years reviewing molecular diagnostic devices with the FDA.
- Proven success in authoring and leading FDA regulatory submissions and interactions, including PMAs, sPMAs, 30Day Notices, 510(k)s, and IDE submissions.
- Strong working knowledge of IVDCDx andor medical device development processes, including design control, change control, and Quality Systems.
- Proven ability to independently manage the preparation and coordination of premarket and postmarket regulatory submissions.
- Successful track record of securing and maintaining product approvals and registrations through effective crossfunctional coordination and strategic problem solving.
- Awareness of, and experience navigating, regulatory issues and challenges associated with diagnostic andor IVDCDx development.
- Excellent analytical skills with high attention to detail.
- Strong written and verbal communication skills with the ability to convey complex issues in a straightforward manner.
- Highly organized and capable of managing multiple priorities across complex projects in a fastpaced environment.
- Selfmotivated and able to work independently and collaboratively with minimal supervision.
- Handson, proactive, and solutionsoriented, with strong negotiation and interpersonal skills.
- Proficient with Microsoft Office, Propel, JIRA, Teams, Confluence, and AI tools is a plus.
Additional InformationHybrid Work Model: At Guardant Health, we have defined days for inpersononsite collaboration and workfromhome days for individualfocused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled inoffice days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better worklife balance while keeping teams connected to advance our science for our patients.
The US base salary range for this fulltime position is $148,600 to $203,660. The range does not include benefits, and if applicable, bonus, commission, or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).
For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this fulltime position is $174,300 to $239,600. The range does not include benefits, and if applicable, bonus, commission, or equity.
Within the range, individual pay is determined by work location and additional factors, including, but not limited to, jobrelated skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.
Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a deskoffice 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 committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, longterm conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]
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.comjobs
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, realworld data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in earlystage 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 DescriptionSenior Regulatory Affairs Manager – Oncology
Position Summary
The Senior Regulatory Affairs Manager Oncology will provide direct regulatory support for Oncology IVDCDx products (Guardant360 CDx and future products such as Tissue IVDCDx) in all stages of the product lifecycle. This role will actively lead and support development and implementation of regulatory strategies, premarket submissions, postmarket 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 handson and will report to the Sr. Director of Regulatory Affairs – Oncology and will liaise closely with regulatory and crossfunctional teams at Guardant Health, to bring innovative cancer screening assays to market and keep them compliant.
Essential Duties and Responsibilities
- Effectively prepare and manage FDA submissions including premarket (PMAs, QSubs, IDEs, BDDs, SIRs) and postmarket (sPMAs, 30Day notices, Annual Reports) regulatory submissions in adherence with applicable regulations for submission to government agencies.
- Represent regulatory affairs in crossfunctional project teams to support both new product development and onmarket 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 crossfunctional 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 crossfunctional 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.
QualificationsQualifications
- Bachelor’s degree in Life Sciences, Engineering, or related discipline with at least 7 years of relevant regulatory affairs experience in an IVD regulatory affairs role, preferably in molecular diagnostics or closely related area; OR an advanced degree with at least 5 years of relevant experience in an IVDCDx regulatory affairs role. Alternatively, at least 3 years reviewing molecular diagnostic devices with the FDA.
- Proven success in authoring and leading FDA regulatory submissions and interactions, including PMAs, sPMAs, 30Day Notices, 510(k)s, and IDE submissions.
- Strong working knowledge of IVDCDx andor medical device development processes, including design control, change control, and Quality Systems.
- Proven ability to independently manage the preparation and coordination of premarket and postmarket regulatory submissions.
- Successful track record of securing and maintaining product approvals and registrations through effective crossfunctional coordination and strategic problem solving.
- Awareness of, and experience navigating, regulatory issues and challenges associated with diagnostic andor IVDCDx development.
- Excellent analytical skills with high attention to detail.
- Strong written and verbal communication skills with the ability to convey complex issues in a straightforward manner.
- Highly organized and capable of managing multiple priorities across complex projects in a fastpaced environment.
- Selfmotivated and able to work independently and collaboratively with minimal supervision.
- Handson, proactive, and solutionsoriented, with strong negotiation and interpersonal skills.
- Proficient with Microsoft Office, Propel, JIRA, Teams, Confluence, and AI tools is a plus.
Additional InformationHybrid Work Model: At Guardant Health, we have defined days for inpersononsite collaboration and workfromhome days for individualfocused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled inoffice days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better worklife balance while keeping teams connected to advance our science for our patients.
The US base salary range for this fulltime position is $148,600 to $203,660. The range does not include benefits, and if applicable, bonus, commission, or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).
For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this fulltime position is $174,300 to $239,600. The range does not include benefits, and if applicable, bonus, commission, or equity.
Within the range, individual pay is determined by work location and additional factors, including, but not limited to, jobrelated skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.
Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a deskoffice 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 committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, longterm conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]
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.comjobs
Senior Regulatory Affairs Manager – Oncology
Position Summary
The Senior Regulatory Affairs Manager Oncology will provide direct regulatory support for Oncology IVDCDx products (Guardant360 CDx and future products such as Tissue IVDCDx) in all stages of the product lifecycle. This role will actively lead and support development and implementation of regulatory strategies, premarket submissions, postmarket 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 handson and will report to the Sr. Director of Regulatory Affairs – Oncology and will liaise closely with regulatory and crossfunctional teams at Guardant Health, to bring innovative cancer screening assays to market and keep them compliant.
Essential Duties and Responsibilities
- Effectively prepare and manage FDA submissions including premarket (PMAs, QSubs, IDEs, BDDs, SIRs) and postmarket (sPMAs, 30Day notices, Annual Reports) regulatory submissions in adherence with applicable regulations for submission to government agencies.
- Represent regulatory affairs in crossfunctional project teams to support both new product development and onmarket 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 crossfunctional 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 crossfunctional 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.
- Bachelor’s degree in Life Sciences, Engineering, or related discipline with at least 7 years of relevant regulatory affairs experience in an IVD regulatory affairs role, preferably in molecular diagnostics or closely related area; OR an advanced degree with at least 5 years of relevant experience in an IVDCDx regulatory affairs role. Alternatively, at least 3 years reviewing molecular diagnostic devices with the FDA.
- Proven success in authoring and leading FDA regulatory submissions and interactions, including PMAs, sPMAs, 30Day Notices, 510(k)s, and IDE submissions.
- Strong working knowledge of IVDCDx andor medical device development processes, including design control, change control, and Quality Systems.
- Proven ability to independently manage the preparation and coordination of premarket and postmarket regulatory submissions.
- Successful track record of securing and maintaining product approvals and registrations through effective crossfunctional coordination and strategic problem solving.
- Awareness of, and experience navigating, regulatory issues and challenges associated with diagnostic andor IVDCDx development.
- Excellent analytical skills with high attention to detail.
- Strong written and verbal communication skills with the ability to convey complex issues in a straightforward manner.
- Highly organized and capable of managing multiple priorities across complex projects in a fastpaced environment.
- Selfmotivated and able to work independently and collaboratively with minimal supervision.
- Handson, proactive, and solutionsoriented, with strong negotiation and interpersonal skills.
- Proficient with Microsoft Office, Propel, JIRA, Teams, Confluence, and AI tools is a plus.
Additional Information
Hybrid Work Model: At Guardant Health, we have defined days for inpersononsite collaboration and workfromhome days for individualfocused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled inoffice days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better worklife balance while keeping teams connected to advance our science for our patients.
The US base salary range for this fulltime position is $148,600 to $203,660. The range does not include benefits, and if applicable, bonus, commission, or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).
For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this fulltime position is $174,300 to $239,600. The range does not include benefits, and if applicable, bonus, commission, or equity.
Within the range, individual pay is determined by work location and additional factors, including, but not limited to, jobrelated skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.
Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a deskoffice 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 committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, longterm conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]
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.comjobs
Qualifications
Qualifications
Required profile
Experience
Other Skills
- Analytical Skills
- Communication
- Quality Control
- Negotiation
- Time Management
- Social Skills
- Problem Solving