Associate Director or Director, Regulatory Affairs

Role Summary

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 Kymera’s I/I portfolio of targeted protein degraders.

Responsibilities

• Develop and execute global regulatory strategies in partnership with the Global Program Regulatory lead for the STAT6 program.
• Collaborate across multiple indications and development programs within the STAT6 program.
• Lead cross-functional teams to advance regulatory submissions and ensure timely delivery of high-quality documents.

Qualifications

• Required: Bachelor’s degree in a scientific discipline; Advanced degree preferred, but not required.
• Required: 8+ years of Regulatory Affairs experience, ideally in immunology and inflammation indications, including direct experience supporting pediatric drug development plans.
• Required: Experience in authoring a broad range of regulatory submissions including briefing documents, Module 2 summaries, and designation requests.
• Required: Demonstrated ability to independently coordinate and drive cross-functional teams to develop complex regulatory submissions with successful outcomes.
• Required: Experience in small molecule mid- and late-stage drug development.
• Required: Excellent understanding of global drug development and regulatory principles and practices, with the motivation to continually learn and build on existing skills and knowledge base.
• Required: Demonstrated ability to lead teams, internal and external, through excellent interpersonal and communication skills.
• Required: 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.

Skills

• Leadership and collaboration across cross-functional teams.
• Excellent interpersonal and communication skills.

Education

• Bachelor’s degree in a scientific discipline; Advanced degree preferred, but not required.