Associate Director Regulatory Affairs

Location
Pennsylvania United States
Posted
19 Nov 2018
End of advertisement period
19 Jan 2019
Ref
40-30430
Contract Type
Permanent
Hours
Full Time

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

School/Center Overview

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/

Duties

The Office of Clinical Research (OCR), Sponsor Support Unit, together with the Perelman School of Medicine (PSOM) is seeking an Associate Director of Regulatory Affairs. This position directs the regulatory aspects of University held applications, is the subject matter expert for assigned regulatory related activities, and leads/contributes to all unit activities. The Associate Director will join the leadership team of the SSU and be responsible for project management of assigned projects and mentorship/project oversight of assigned regulatory team members. Additionally, the AD is responsible for the supervision, preparation and critical review of high quality regulatory submissions to the FDA and other global Authorities, including INDs, IDEs, and CTAs, amendments, annual reports, safety reporting, overall planning and direction of regulatory activities, and developing and implementing strategies with the goal of prompt approval of regulatory submissions. The AD will establish, build, and navigate new relationships with sponsors, sponsor team members, and vendors to ensure the success of the project, unit, and university. This position will work in tandem with the Director of the Sponsor Support Unit to provide direct guidance to new and current IND, IDE, and CTA sponsors in the PSOM and troubleshoot/problem solve as needed.

Qualifications

Master’s degree and 5-7 years of experience in drug and device development or an equivalent combination of education and experience required. Master’s degree in Regulatory Affairs preferred. RAC preferred. Direct experience with the FDA required and some experience with Health Canada and EMA member states required. Possess strong communication, management, and organizational skills.

Affirmative Action Statement

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements  

Quick Link

http://jobs.hr.upenn.edu/postings/41663