Associate Director or Director, Regulatory Affairs

Bachelor’s degree in a scientific discipline; Advanced degree preferred but not required. 8+ years of Regulatory Affairs experience, ideally in immunology and inflammation indications, including direct experience supporting the design and execution of pediatric drug development plans. Experience in directly authoring a broad range of regulatory submissions including briefing documents, Module 2 summaries, and designation requests. Demonstrated ability to independently coordinate and drive cross-functional teams to develop complex regulatory submissions with successful outcomes. Experience in small molecule mid- and late-stage drug development is required. Excellent understanding and knowledge of global drug development and regulatory principles and practices with the motivation to continually learn and build on existing skills and knowledge base. Demonstrated ability to lead teams, internal and external, through excellent interpersonal and communication skills. A self-starter willing to take on new challenges, work outside their areas of comfort and collaborate cross-functionally to contribute to the success of their programs.