Associate Director or Director, Regulatory Affairs (Hybrid 3 days in office)
How you’ll make an impact:
The Associate Director or Director of Regulatory Affairs will be a key member of the STAT6 Regulatory team working in partnership with the Global Program Regulatory lead to develop and execute on innovative and creative global regulatory strategies. This will be a dynamic role within the RA function working across multiple indications and development programs within the STAT6 program. As a critical member of a growing RA organization, this role will leverage their recent and relevant hands-on experiences developing immunology treatments to help rapidly advance Company’s I/I portfolio of targeted protein degraders.
Skills and experience you’ll bring:
- 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 and 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.