DIRECTOR, REGULATORY AFFAIRS
Duties: The 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.
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.
As the DRA, you will partner with critical stakeholders (federal, nonprofit, and commercial) to develop and implement robust global regulatory affairs strategy, including expedited pathways for novel therapeutics in humans that emerge from the R&D activities of GTP. Partner with the Regulatory Writer to provide guidance and strategy for all documents submitted to regulators. Acting as the Subject Matter Expert and voice of Regulatory Affairs, you will participate in multi-disciplinary project team meetings and must have the ability to influence non-direct reports. Also, 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 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: 40-26453
Salary Grade: 029
Employment Type: Exempt
Org: DM-Gene Therapy Program
Job Family: B-Executive/Managerial Administration