Director, Regulatory Strategy and Project Management

Job Summary:

Responsibilities:

• Acts as regulatory representative on early and late phase clinical studies, ensuring compliant execution of trials
• Prepares and coordinates regulatory submissions (ie clinical trial applications, formal meeting documentation, life-cycle management submissions, etc.); supports preparations and submission of INDs and marketing applications, as applicable
• Supports and organizes preparations for Health Authoring meetings and teleconferences.
• Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
• Works within cross-functional teams to provide global regulatory expertise in support of the development, review, and approval of strategies and documents intended to enable clinical trials and marketing authorizations
• Guides and executes regulatory strategy for long-term development planning, including the potential to accommodate expedited development needs
• Collaborates effectively with cross-functional teams and contract research organizations, clearly defining regulatory expectations
• Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
• Ensure adherence to current regulations associated with regulatory activities
• Works with strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
• Plays 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
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Serves as a key subject matter expert in the development, implementation, maintenance, and training for all systems as needed
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed

Experience and Skills:

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• 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