Lead Regulatory Affairs and Quality Assurance activities for Guardant Health Japan, managing regulatory submissions, QMS operations, and quality oversight for oncology in vitro diagnostic devices and related products.
Responsibilities
Drive regulatory strategy and submission activities in Japan
Prepare and review regulatory submission documents
Coordinate communications with PMDA and MHLW
Lead QMS operations and continuous improvement
Oversee QA processes including SOP lifecycle, deviations, CAPA
Requirements
Bachelor’s degree or higher in science, such as chemistry, physics, biological sciences, engineering, or a related technical field
Nice to have: Advanced degree in a business or technical field
Nice to have: Experience with NGS or precision medicine
Nice to have: Experience serving as a Hinseki / Quality Responsible Person
Nice to have: Experience working within a Marketing Authorization Holder quality management environment
Clinical leader responsible for providing clinical evaluation of potential in-licensing or acquisition opportunities and supporting cross-functional discussions with discovery research platforms for molecules in immunological disorders.
Compensation
Pay Range: $273,000.00-372,000.00 Annual
Responsibilities
Provide clinical input into the overall assessment of external molecules as a member of Due Diligence teams
Contribute clinical input to cross-functional planning for molecules emerging from Insmed discovery platforms at the Late Lead Optimization stage
Serve, as needed, on transition teams for molecules that are in-licensed, acquired, or partnered
Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care across relevant disease areas
Partner with Global Clinical Development functions to monitor benefit–risk profiles, manage safety signals, and support regulatory communications or meetings
The Director, Global PV Management is responsible for assessing regional and international pharmacovigilance regulatory requirements and translating them into effective drug safety & pharmacovigilance procedures and operational processes.
Locations (3)
San Francisco, California, United States
San Diego, California, United States
Princeton, New Jersey, United States
Compensation
$194,600—$243,300 USD
Responsibilities
Review and interpret applicable international and regional pharmacovigilance regulatory requirements
Continuously monitor changes to pharmacovigilance requirements in countries where the company operates
Assess pharmacovigilance requirements for new countries and develop operational readiness plans
Conduct and document gap assessments comparing regulatory requirements with existing SOPs
Lead GCP inspection readiness and execution, managing audit activities and coordinating with cross‑functional teams to ensure compliance with global regulatory requirements.
Compensation
For US based candidates, the proposed salary band for this position is as follows: $156,000.00---$234,000.00
Responsibilities
Ensure GCP inspection readiness across cross‑functional clinical study teams
Oversee end‑to‑end inspection planning and execution including logistics and stakeholder coordination
Lead and oversee GCP inspection readiness/preparation activities and serve as an inspection lead for regulatory health authority inspections
Collaborate with cross‑functional clinical study teams to develop and execute risk‑based inspection readiness/preparation strategy
Manage inspection readiness/preparation activities, including development and maintenance of inspection storyboards
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