Associate Director, Regulatory Affairs (Gene Therapy Dept.)
Job location: Translational Research Laboratories
Employment Type: Full-time
Posted data: 2020-10-15
University OverviewThe 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.Posted Job TitleAssociate Director, Regulatory Affairs (Gene Therapy Dept.)Job Profile TitleAssociate Director EJob Description SummaryThe Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.
The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the “go-to” organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.
Continuation of all GTP positions is contingent upon funding.Job Description
Due to growth, we are currently on the hunt for an Associate Director, Regulatory Affairs to navigate researcher teams through the pre-IND and IND filing process for Phase I/II human clinical trials and beyond supporting programs within GTP.
As the Associate Director, you will provide support to GTP with the primary focus being working with collaboration/partnered where the External Sponsor is the IND holder to develop and implement robust global regulatory affairs strategy, including expedited pathways for novel therapeutics in humans that emerge from the R&D activities. You will partner with the Regulatory Writer, Regulatory Operations, and other supporting staff within GTP to provide guidance and strategy for all regulatory documents. Acting as the Subject Matter Expert for topics related to Regulatory Affairs, you will participate in multidisciplinary
project team meetings within GTP, as well as, those arranged by the Office of Clinical Research. The ability to influence and successfully negotiate a mutually agreed upon strategy and approach for these programs is an important attribute. You will monitor current and proposed regulatory, scientific, and pertinent legal issues globally, and perform competitive intelligence to provide an assessment of the impact on product development and IND compliance.
Joining GTP and ODC offers professionals the unique opportunity of directly affecting research and discoveries that could one day lead to cures.
- Bachelor degree (or equivalent) within a relevant subject such as biology, pharmacy, chemistry or a related scientific discipline and 3-5 years of pharmaceutical or biotech company experience.
- Experience with global regulatory activities for assigned projects and respond readily to changing events and priorities.
- Experience with strategy development and creation of submission documents from early phase clinical submissions (IND) and lifecycle management activities.
- Ability to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new biopharmaceutical products, to expedite the submission, review and approval of global applications.
- Experience working on cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development, quality and manufacturing.
- Experience maintaining high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
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
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.