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About the role
Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology – Solid Tumors) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team working in close collaboration with the SVP, Head of Regulatory Affairs and other cross-functional colleagues.
What they're looking for
- Bachelor's degree in life-sciences or related scientific discipline, advanced degree preferred
- Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the oncology (solid tumors) therapeutic area
- Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
- Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
- Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
- Strong project management and critical thinking skills
More about this role
Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology – Solid Tumors) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team working in close collaboration with the SVP, 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.
- Develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of...
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