Director/Sr. Director, Regulatory Affairs (Strategy, Hematology) - Remote

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary :

Nurix Therapeutics, Inc. is seeking a Director / Sr. Director, Regulatory Affairs (Strategy, Hematology) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team working in close collaboration with the VP, Head of Regulatory Affairs and other cross-functional colleagues. This role will be responsible for developing and executing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy, guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of registration and life cycle management activities. This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required.

Responsibilities :

• Develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions.
• Identify potential risks and mitigation strategies associated with proposed strategies.
• Represent Regulatory Affairs on assigned cross-functional development teams.
• Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable.
• Lead communication with global Health Authorities (HA), such as FDA and EMA, including planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
• Develop and execute, or oversee global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs.
• Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges. Provide insight and guidance on the implementation of current regulations and assess regulatory risk based on precedence.
• Ensure adherence to current regulations associated with regulatory activities.
• Work strategically with all regulatory functions to develop detailed, actionable submission plans, track major submission deliverables, and ensure consistent management of submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications.
• Play an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management.
• Track the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies.
• Develop and maintain submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs.
• Participate in cross-functional process initiatives impacting regulatory submission processes and systems.
• Manage consultants and contractors as needed.

Experience and Skills :

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https : / / www.nurixtx.com / privacy-policy /

J-18808-Ljbffr