1. Directs one or more functional areas within an administrative department of the University and ensure compliance with University policies and procedures. 2. Directs analytic and research support for educational policies and planning and develops and approves administrative policies affecting assigned functional areas of the University. 3. Directs and establishes parameters for major projects for the department and University. 4. Interprets federal policies and regulations and educates staff and administration about regulations, restrictions, and the legal responsibilities of the University. 5. Directs and implements policy and program modifications and develops standards to ensure compliance with federal, state and local regulations. 6. Develops and administers an operating budget for the assigned department consistent with University policies and procedures. 7. Develops cost savings objectives and goals; authorizes major purchases and negotiates contracts that range from routine to complex in nature. 8. Establishes and implements long- and short-range goals for the functional area consistent with University goals and objectives. 9. Directs the development of related automated systems to support the function; determines office policies and procedures for use of automated systems. 10. Directs the evaluation and selection of vendors and negotiates contract details including work steps and pricing with the vendors on behalf of the assigned functional area. 11. Works with internal and external contacts to solve problems that range from routine to complex in nature. 12. Represents the University in discussions and negotiations with various governmental agencies. 13. Directs a staff of exempt and nonexempt employees. 14. May perform other duties as assigned.
Preferred Education: A BA/BS degree or equivalent with minimum of 5 years direct regulatory supervisory experience, plus 7 years of regulatory experience. Advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.
Preferred Education, Experience and Skills: A BA/BS degree or equivalent with minimum of 5 years direct regulatory supervisory experience, plus 7 years of regulatory experience. Advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.
Posting Position Title: Director 3
Required Skill/ability 3: Ability to motivate, develop, and assess learning capacity of direct reports.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Director of YCC Regulatory Affairs YCC CTO
Required Skill/ability 1: Ability to clearly communicate and understand written information.
Required Skill/ability 2: Ability to analyze ideas, use logic, and recognize the nature of issues to develop creative problem-solving opportunities.
Bachelor's Degree in related field. Seven years of experience or an equivalent combination of education and experience.
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.