Associate Director, Inspection Management
This position is 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 position supports cross-functional teams in inspection readiness, ongoing inspections, and inspection follow-up and maintaining inspectional databases. This function may also serve as a scribe during health authority inspections and/or partner audits. The individual works with department leaders to build capabilities across the organization at non-manufacturing facilities.
In this role, a typical day might include the following:
- Assist in the maintenance a consistent process for inspection readiness and management across clinical projects
- Actively participate in all Good Clinical Practice (GCP) inspection readiness meetings, attend functional department meetings and Study Management team meetings to 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)
- Works with Clinical Study team members to provide support and to ensure inspection preparation results 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
- 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
- Assist in the Communication of lessons learned within CDRA in collaboration with the entire Clinical Compliance & Training team (incl. Compliance, Process & Procedures and Training)
- Support CCT and QA, as needed, by participating in the conduct of investigator site Inspection Readiness Visits
- Support GLP Inspection Readiness activities, as needed
- Serves as back up to the Director, as appropriate
- 5+ years of regulatory compliance experience and leading regulatory inspections in one of the following areas: GCP
- Knowledge and experience in preparing and conducting regulatory authority inspection practices internally, externally, domestic and internationally
- Extensive experience managing and supporting regulatory authority inspections of clinical research activities
- Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH Guidelines
- Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials
- Strong working knowledge of clinical development and operations
- Excellent verbal, written communication and presentation skills
- Experience in providing training on key quality and regulatory compliance information
- Strong partnering and collaboration skills
- Willing to work to function at all levels of the organization including functioning as an individual contributor as needed.
- Balanced approach to issue management and mitigation planning
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 maternity 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.