1. Supervise the day to day work of assigned regulatory staff. Accomplish staff results by communicating job expectations, planning, monitoring and evaluating results. Perform coaching, mentoring, progressive counseling, and disciplining, as needed. Provide performance feedback. 2. Maintain staff by recruiting, selecting, onboarding and training regulatory staff within assigned DARTs. 3. Review status of initial approvals, amendments, renewals and post-approval issues within assigned DARTs to ensure regulatory compliance. Devise corrective action plans as needed to address instances of non-compliance. Ensure efficiency at each step in the process. 4. Under direction of the Director, Regulatory Affairs, assist with creation, revision and implementation of regulatory unit standard operating procedures (SOP). Train appropriate staff on new SOPs. 5. Maintain regulatory compliance and project management for single center Investigator-Initiated Clinical Trials where the IND is held by a Yale Investigator. Liaise with IND Coordinator to ensure compliance with Code of Federal Regulations. 6. Conduct routine monitoring of regulatory binders for Investigator-Initiated and Cooperative group studies within assigned DARTs. 7. Conduct quality assurance reviews of regulatory binders in preparation for internal and external audits and/ or inspections, as assigned by your supervisor. 8. Maintain professional knowledge on appropriate regulations and processes related to regulatory compliance in clinical trials. Attend educational workshops, review professional publications and disseminate knowledge to group.
Required Skill/ability 5: Proven ability to onboard, train and mentor junior regulatory staff. Previous ability in providing constructive feedback to direct reports and in escalating issues as necessary to Assistant Director of Regulatory Affairs. Ability to establish and assign the activities of multiple teams to accomplish study goals.
Posting Position Title: Regulatory Manager, YCC
Required Skill/ability 3: Demonstrated knowledge of oncology language and federal regulations involving human subjects. Proven ability to work successfully within a team environment and as an individual contributor. Flexible to adjust work schedule to allow for team priorities to be met.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Regulatory Manager
Required Skill/ability 1: Demonstrated knowledge of regulatory affairs in areas of FDA-regulated clinical research, Investigational New Drug and Investigational Device submissions and management, audits, monitoring visits and NIH and NCI regulations and reporting requirements.
Required Skill/ability 4: Proven ability to manage several projects concurrently, while balancing competing priorities and deadlines. Extreme flexibility in work focus. Proven ability to switch among several different projects without any adverse effects.
Required Skill/ability 2: Strong analytical and writing skills combined with the ability to communicate effectively and diplomatically in written and verbal forms with internal and external contacts (NIH, FDA, industry) faculty, researchers and staff at all levels while coordinating clinical trials.
Bachelor's Degree and 3 years of regulatory experience or an equivalent combination of education and experience.
Internal Number: 53293BR
About Yale University
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.