Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

Role: Senior Manager/Associate Director of Regulatory Affairs (Strategy) focusing on hematology oncology at Nurix Therapeutics, responsible for developing and executing global regulatory strategies for clinical and marketing programs. Responsibilities include providing strategic direction for regulatory submissions, supporting clinical trial and product life cycle management, ensuring compliance with US and international regulations (FDA, EMA, ICH), and managing communication with regulatory authorities. The role involves preparing key regulatory documents (INDs, CTAs, NDAs, DSURs), overseeing submission plans, maintaining regulatory tracking systems, and collaborating cross-functionally to mitigate risks and ensure compliance throughout development. The position also requires contributing to regulatory systems and tools development and managing external consultants. Requirements include a Bachelor’s in life sciences with at least 8 years in regulatory affairs strategy, strong knowledge of drug development regulations, experience supporting clinical trial and marketing applications, and project management skills using tools like MS Project or Excel. Preferred qualifications include advanced degrees and extensive experience in hematology/oncology therapeutics, biologics, or targeted protein degradation modalities, with a focus on early to late-stage development. The role is based onsite in Brisbane, CA, with a solutions-oriented, collaborative cultural fit and strong regulatory expertise necessary to support Nurix’s innovative platform in targeted protein degradation.