Director, Regulatory Strategy and Project Management

August 30

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Nurix Therapeutics

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Targeted protein degradation is only the beginning. Blazing a new path in medicine.

research • life sciences • biotechnology

201 - 500

💰 $40M Post-IPO Equity on 2022-07

Description

• Nurix Therapeutics, Inc. is seeking a Director, Regulatory Strategy and Project Management. • Responsible for guiding and executing regulatory strategy of clinical submissions. • Acts as regulatory representative on clinical studies, ensuring compliance. • Prepares and coordinates regulatory submissions including INDs and marketing applications. • Supports and organizes Health Authoring meetings and teleconferences. • Develops and executes global regulatory strategy for long-term planning. • Works within cross-functional teams to provide regulatory expertise. • Tracks major deliverables for regulatory submissions and their dependencies. • Manages consultants and contractors as needed.

Requirements

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred • Must have minimum of 12 years in Regulatory affairs strategy with 4 years or more ideally managing others • 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 • 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