Senior Manager / Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

Senior Manager / Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

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:

In this role, you 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.

Responsibilities:

Provides regulatory strategic direction and support for assigned global development programs/development program activities

Assists Sr. Regulatory Affairs staff with their development program activities and deliverables

Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management

Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials

Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities

Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities

Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications

Assist in the cataloging and maintenance of regulatory application submissions

Conduct research and stay up-to-date on regulatory requirements and changes

Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle

Monitor and assess regulatory risks and develop mitigation strategies

Oversee quality assurance processes to ensure compliance with regulatory standards

Review SOPs pertaining to Regulatory

Works 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

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 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

Fit with Nurix Culture and Values

Strong team orientation; highly collaborative

Solutions and results-oriented focus

Hands-on approach; resourceful and open to diverse points of view

Salary Range: SM $187,800 - $208,638 AD $199,500 - $231,200

Location: Brisbane, CA - Onsite