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Director/Sr. Director, Regulatory Affairs (Strategy, Immunology and Inflammation)

Employer
Nurix Therapeutics
Location
San Francisco, CA
Start date
Oct 31, 2024
View more categoriesView less categories
Discipline
Marketing, Regulatory, Science/R&D, Immunology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details


Job Summary:

Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team.  The successful candidate will be a core member of the Regulatory team and will serve as the global regulatory lead (GRL) for the immunology and inflation therapeutic area. This role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities.

This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required.


Responsibilities:

  • Develop and implement competitive and effective global clinical & nonclinical regulatory strategies for various immunology and inflammation indications and identify potential risks and mitigation strategies associated with proposed strategies
  • Work in close collaboration with the VP, Head of Regulatory Affairs and the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plans
  • Represent Regulatory Affairs on assigned cross-functional development teams.
  • Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable
  • Lead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
  • Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
  • Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges 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 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 12 years in Regulatory affairs strategy with significant experience in the immunology and inflammation therapeutic area
  • 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

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 (https://www.nurixtx.com/privacy-policy/). 

Company

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.

Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.

Company info
Website
Phone
415-660-5320
Location
1700 Owens Street
Suite 205
San Francisco
California
94158
US

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