DIRECTOR, REGULATORY AFFAIRS
Duties: The Gene Therapy Program (GTP) and Orphan Disease Center (ODC) are 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.
Orphan diseases represent a collection of disorders that afflict fewer than 200,000 individuals for any single disease type, yet there are more than 7,000 distinct orphan diseases. The goal of the Orphan Disease Center is to address these growing needs through continued collaboration and partnership, identifying and providing funding sources, and by providing technological and educational resources to academic researchers, bioetch and pharmaceutical companies alike, to foster therapeutic development and innovative research initiatives.
We are currently on the hunt for a Director, Regulatory Affairs (DRA) 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 and ODC. This position reports to the Executive Director of Regulatory Affairs and Compliance within GTP and ODC.
As the DRA, 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 and ODC, 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.
In addition, the DRA will provide support to ODC to assist with the development of natural history and registry studies that may be used to support registration for rare and ultra-rare orphan diseases.
Joining GTP and ODC offers professionals the unique opportunity of directly affecting research and discoveries that could one day lead to cures.
Qualifications: Master's degree and at least 5 to 7 years of experience working in a regulatory capacity in the biotechnology or pharmaceutical industry or an equivalent combination of education and experience required.
Preferred candidates will have experience working as a lead in Regulatory Affairs for regulatory strategy for IND submissions
Preferred candidates will have experience with biologics submissions.
Ability to interact effectively with external business partners and regulatory agencies
Demonstrated excellence in leadership with ability to influence people in a complex, changing environment
Strong strategic skills in creativity and effectiveness in identifying and addressing major strategic challenges
Excellent verbal and writing skills with the ability to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders
Skilled in conflict resolution; fostering open communication with attention to listening and facilitating discussion
Strong negotiating skills with a creative solution-oriented focus.
Ability to prioritize and handle multiple project priorities
Reference Number: 40-27790
Salary Grade: 029
Employment Type: Exempt
Org: DM-Gene Therapy Program
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.
Job Family: B-Executive/Managerial Administration