Associate Director, Inspection Management
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, New York, United States of America
- Start date
- Jul 2, 2021
View more
- Discipline
- Quality, Quality Assurance, Quality Control, Regulatory, Legal/Compliance, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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.
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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