Director/Sr. Director, Head of Regulatory Affairs Policy, Intelligence and Data Transparency (R[...]

Company: Nurix Therapeutics
Location: San Francisco
Posted on: January 29, 2025

Job 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 Director/ Sr. Director, Head of Regulatory Affairs Policy, Intelligence and Data Disclosure and Transparency (DD&T) 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. They will be a strong subject matter expert in regulatory processes, laws, and regulations, with a comprehensive understanding of how regulatory policy is shaped and developed with Europe and the US. The individual will also have extensive knowledge of clinical trial transparency regulations, track and inform about new DD&T requirements, developments, and latest updates as appropriate.This role will coordinate efforts in a highly collaborative cross-functional environment that addresses global policy & intelligence gathering, analysis of changes in the regulatory environment, coordination of policy positions and advocacy strategies to achieve policy goals, working collaboratively with both internal and external stakeholders to influence the policy environment set by global Health Agencies. This individual will work closely with RA colleagues to coordinate policies around the Nurix portfolio-assessing the impact of regulatory policy on products and goals.Responsibilities:

• Coordinates and executes regulatory intelligence and policy strategies and operations to address current and future business needs in partnership with internal global, regional, and country level RA functions.
• Understands draft legislation, regulations, guidelines, and policies at the global level, and supports interactions and communications with trade associations and health authorities on regulatory policy matters relevant to organizational positions.
• Effectively supports Nurix's positions and serves as a representative internally and externally on key policy topics to appropriately coordinate engagements within the regulatory environment as well as engage with medical societies and key industry trade associations.
• Provides insights and coordinates for global "one voice" positions on critical regulatory issues and trends to contribute to a broader policy platform.
• Coordinates the deployment of regulatory Intelligence resources and tools as well as access to them and provides focused regulatory insights to the RA organization and other stakeholders.
• Provides strategic expertise, possessing functional and soft skills to drive strategic intelligence and policy goals.
• In collaboration with regulatory writing, authors and submits transparency submissions, including global clinical trial registrations, tabular results, plain language results summaries and/or performs document redactions throughout the study lifecycle in accordance with Nurix policy and international regulations.
• Facilitates cross-functional team review and approval of transparency submissions on time and within compliance with regulatory and Nurix requirements.
• Maintains and updates data disclosure tracking tools and dashboards to comply with applicable transparency requirements.
• 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.
  • Minimum of 12 years in Regulatory affairs experience with practical knowledge and expertise in Regulatory intelligence & policy with the EU and/or US.
  • Proven capability in acting as a credible, influential, and respected spokesperson able to convey complex messages, trends & insights.
  • Deep understanding of the regulatory environment and latest regulations and guidance with sound knowledge of intelligence tools and methods; preference will be given to candidates with therapeutic area experience (i.e., oncology).
  • Strong relationship management and interpersonal skills with superb written and oral communication skills.
  • Proven success at stakeholder engagement across organizational levels and boundaries.
  • Ability to work independently as well as part of a team environment.
  • Excellent organizational and communication skills, both written and verbal.
  • Positive attitude, energetic and proactive.
  • Proven ability to manage multiple projects, identify and resolve issues.
  • Strong interpersonal skills and the ability to effectively work with others.
  • Willingness and ability to create and share knowledge.
  • Critical thinker with ability to organize workload, work well under pressure, define priorities and deliver under tight timelines.
  • Conflict management skills.
  • Strategic and visionary personality who is focused, creative, courageous, and able to navigate ambiguity while balancing short-term priorities and long-term vision.
  • Willingness and ability to apply scientific knowledge and have sound scientific discussions.
  • Ability and willingness to learn continuously, adapt to a changing environment and improve efficiency.
  • Skilled in relevant IT applications (Microsoft Office applications as well as regulatory databases and other relevant IT applications) and willingness to learn relevant IT applications and to make use of the benefits of relevant IT applications.
  • Excellent project management 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 ().
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Keywords: Nurix Therapeutics, San Jose , Director/Sr. Director, Head of Regulatory Affairs Policy, Intelligence and Data Transparency (R[...], Executive , San Francisco, California