We want you to be an integral part of the team that leads regulatory inspections through prep, performance and follow-up of items requested by international regulatory agencies and partner audits. This position leads inspection content ensuring it is organized, current and readily accessible. This function may also serve as a scribe during health authority inspections and/or partner audits.
In this role, a typical day might include the following:
- The incumbent must have experience in the following areas for consideration into this role: GCP, GLP, and/or GPV.
- Assist in the maintenance of a consistent process for inspection readiness and management across clinical projects
- Actively participate in all Good Clinical Practice (GCP) inspection readiness meetings and ensure inspection readiness activities and expectations are communicated in a timely manner
- Support Inspection Management Plans that include activities to build inspection readiness into the development process (e.g. conduct study start-up inspection ready assessments)
- We expect you to work with Clinical Study team members to provide support and to ensure inspection preparation materials are met per required timelines
- Identifies gaps and issues and works with team(s) to develop CAPAs and/or strategies to mitigate risks prior to and during inspections
- We need you to assists both internal REGN teams and external (eg, vendor, PI site staff) with inspection preparation activities (mock interviews/inspections, training, preparation visits)
- Assists the Clinical and Quality Auditing teams in preparation, conduct and tracking of issues for Site Inspection Readiness.
- Follow-up on all inspection commitments, responses, post-inspection activities, corrective and preventative actions, and resolve all issues for timely closure
This role may be for you if:
We seek extensive experience leading and supporting regulatory authority inspections of clinical research activities
Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials
Willing to work at all levels as needed including functioning as an individual contributor as needed.
To be considered The incumbent must have experience in the following areas for consideration into this role: GCP, GLP, and/or GPV. You should have 5+ years of regulatory compliance experience and managing regulatory inspections in GCP. Solid understanding and experience in preparing and conducting regulatory authority inspection practices internally, externally, domestic and internationally.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.