The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Yale University, conveniently located between Boston and New York, offers exciting opportunities for achievement and growth in New Haven, Connecticut. Located in the heart of historic downtown, New Haven is home to more than 100 local boutiques, national retailers, cafés, casual eateries, award-winning restaurants, and world-renowned theaters, galleries, and museums.
Acts as sole leader of the Clinical Trials Office regulatory division, overseeing the central regulatory teams including Senior Regulatory Project Managers, Regulatory Project Managers, Regulatory Managers, Regulatory Assistants, Research Assistants, and CTRP functions for the Yale Cancer Center. Creates functional strategies and specific objectives for the regulatory team, developing workflows, implementing policies and procedures, monitoring compliance, educating colleagues, and assessing performance of employees to support the functional infrastructure. Works in partnership with other Assistant Directors within the Clinical Trials Office (CTO) to ensure compliance, coordination, and cohesive communication across all aspects of the CTO.
Required Education and Experience:
Bachelor’s Degree in related field and eight years of experience or an equivalent combination of education and related experience.
Ability to clearly communicate and understand written information.
Ability to analyze ideas, use logic, and recognize the nature of issues to develop creative problem-solving opportunities.
Ability to motivate, develop, and assess learning capacity of direct reports.
Preferred Education and Experience: 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.ACRP/SoCRA (or equivalent) certification preferred. Knowledge of National Cancer Institute Cancer Center Support Grant (NCI CCSG P30) preferred.
Application: For more information and immediate consideration, please apply online at http://bit.ly/YaleCareers-63301BR. Please be sure to reference this website when applying for this position.
We invite you to discover the excitement, diversity, rewards and excellence of a career at Yale University. One of the country's great workplaces, Yale University offers exciting opportunities for meaningful accomplishment and true growth. Our benefits package is among the best anywhere, with a wide variety of insurance choices, liberal paid time off, fantastic family and educational benefits, a variety of retirement benefits, extensive recreational facilities, and much more.
Yale University considers applicants for employment without regard to and does not discriminate on the basis of an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression.
Since its founding in 1701, Yale University has been dedicated to expanding and sharing knowledge, inspiring innovation, and preserving cultural and scientific information for future generations. Yale’s reach is both local and international. It partners with its hometown of New Haven, Connecticut to strengthen the city’s community and economy. And it engages with people and institutions across the globe in the quest to promote cultural understanding, improve the human condition, delve more deeply into the secrets of the universe, and train the next generation of world leaders.
Yale offers exciting opportunities for achievement and growth in New Haven, Connecticut. Conveniently located between Boston and New York, New Haven is the creative capital of Connecticut with cultural resources that include three major museums, a critically-acclaimed repertory theater, state-of-the-art concert hall, and world-renowned schools of Architecture, Art, Drama, and Music.
We invite you to discover the excitement, diversity, rewards and excellence of a career at Yale University. One of the country's great workplaces, Yale University offers exciting opportunities for meaningful accomplishment... and true growth. Our benefits package is among the best anywhere, with a wide variety of insurance choices, liberal paid time off, fantastic family and educational benefits, a variety of retirement benefits, extensive recreational facilities, and much more.