Manager - Regulatory Affairs, Strategy, Hematology Oncology

January 23

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

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Nurix Therapeutics

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Nurix Therapeutics is a biotechnology company that is leading the field of protein modulation to develop innovative medicines for cancer and inflammatory diseases. The company leverages its proprietary DELigase platform to create small molecule drugs that harness the activity of E3 ligases, enzymes crucial for protein degradation within cells. Nurix's approach involves both targeted protein degradation, which eliminates specific disease-causing proteins, and targeted protein elevation, which prevents protein degradation to raise levels of beneficial proteins. Through its advanced pipeline, Nurix aims to meet the unmet medical needs of patients by empowering the body's natural ability to fight disease.

research • life sciences • biotechnology

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $40M Post-IPO Equity on 2022-07

📋 Description

• 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 Manager/Sr. Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team. • The successful candidate will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products, for guiding and executing upon regulatory strategy of compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. • This includes supporting regulatory activities to enable clinical development plans and studies, working cross-functionally across the organization.

🎯 Requirements

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager: • Must have minimum of 8 years in Regulatory affairs strategy • 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 • Ability to read, analyze and interpret scientific and technical information, as well as regulatory • Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external • Ability to comply with changing regulatory • 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 • Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions • Excellent organizational and communication skills, both written and verbal • Ability to work independently as well as part of a team environment • Positive attitude, energetic and proactive • Proven ability to manage multiple projects, identify and resolve regulatory issues • Strong interpersonal skills and the ability to effectively work with others