Executive Director, Regulatory Science
About the Company
Innovative provider of gene therapies to people with rare diseases
Industry
Biotechnology
Type
Subsidiary of a Public Company
Founded
2015
Employees
51-200
Categories
Specialties
Business Classifications
About the Role
The Company is seeking an Executive Director for Regulatory Science to play a pivotal role in defining and executing US regulatory strategies across the pipeline. The successful candidate will serve as a senior advisor to program regulatory teams, ensuring a consistent global approach to regulatory strategies. This includes leading the preparation and review of meeting requests, briefing documents, and other strategic regulatory filings, as well as maintaining strong relationships with the US FDA. The role also involves leading US regulatory intelligence and policy activities, monitoring and disseminating relevant regulatory updates, and participating in industry associations to advocate for critical regulatory matters. The Executive Director will have line management responsibilities and will be accountable for the team's adherence to GxP and relevant policies. Applicants for the Executive Director position should have a PharmD or PhD in a scientific discipline, with at least 15 years' experience in regulatory affairs within the biotech environment. A background in the preclinical and clinical development of gene or cell-based therapies is highly desired. The ideal candidate will have a deep understanding of FDA regulations, particularly in the areas of rare diseases and pediatrics, and a proven track record in leading major FDA interactions. Strong leadership, interpersonal, and communication skills are essential, as is the ability to work in a cross-functional, multi-cultural team environment. The role requires a strategic, innovative thinker who is highly accountable, dependable, and capable of managing multiple priorities in a fast-paced, dynamic setting.
Hiring Manager Title
VP of Regulatory Science
Travel Percent
Less than 10%
Functions
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