Associate Director/Director, Regulatory Intelligence

Location
San Francisco, CA, United States
Posted
Aug 01, 2021
Ref
5368399002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

Position

The regulatory intelligence director will bring expertise on approval strategies of other products related to the disease areas under study, will continuously collect and build an up-to date knowledge base of competitor's products and their approval pathways that will be shared with the project teams and Company management. The position will also ensure up to date knowledge of FDA regulations, guidelines, and current policy are shared and clearly communicated, from general compliance regulations through product specific guidance and clinical data requirements for specific approvals.

Key responsibilities
  • Proactively research FDA and other HA policies, regulations, and guidance.
  • Build in-depth insight in regulatory approval policies and trends.
  • Develop written competitive analyses and share/present to the company teams/management
  • Provide support within the regulatory team
  • Stay up to date on new regulations and new guidance (US and ex-US)
  • Attend advisory committees, workshops, conferences; gather relevant information for the development projects of the company
  • Share detailed knowledge of other approved products, pivotal studies, label claims

Requirements
  • Advanced degree in life sciences
  • 8 years of industry experience
  • Must have oncology/immuno-oncology experience
  • Ethical mindset, team player
  • Ability to self-organize; plan and execute a high workload
  • Able to prepare professional high-quality presentations
  • Outstanding communicator (writing and speaking)
  • Strong problem solving and analytical skills