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Kymera Therapeutics · 3 days ago

Associate Director or Director, Regulatory Affairs

Greater Boston

Full-time

Onsite

Lead/Staff, Director/Executive

$160K/yr - $275K/yr

8+ years exp

Kymera Therapeutics is a clinical-stage biotechnology company focused on developing targeted protein degradation medicines. The Associate Director or Director of Regulatory Affairs will play a key role in developing and executing global regulatory strategies for immunology treatments, working closely with the Global Program Regulatory lead.

BiotechnologyHealth CareMedicalTherapeutics

Growth Opportunities

Responsibilities

Develop and execute on innovative and creative global regulatory strategies

Work across multiple indications and development programs within the STAT6 program

Leverage hands-on experiences developing immunology treatments to help advance Kymera’s I/I portfolio of targeted protein degraders

Qualification

Regulatory Affairs experienceImmunology treatmentsRegulatory submissions authoringSmall molecule drug developmentGlobal drug development knowledgeCross functional team coordinationInterpersonal skillsCommunication skillsSelf-starterCollaboration

Required

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