Regulatory Affairs Associate/Sr. Regulatory Affairs Associate

Regulatory Affairs (800) · Oakland, California
Department Regulatory Affairs (800)
Employment Type Full-Time
Minimum Experience Entry-level

Company:

 

Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1b trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.

 

Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Oakland, CA.


Position:

 

As a key member of the Regulatory Affairs team, the Regulatory Affairs Associate is responsible for maintaining the regulatory tracking systems, coordination, and review of regulatory submission documents, and may serve as the liaison for multi-functional development teams that support early- and late-stage clinical development of investigational products. This person will be assigned a diverse scope of job activities and will partner with senior internal staff who will provide direction, and opportunity for growth.

 

 Responsibilities include:

  • Support the Regulatory Affairs team
  • Compile and maintain regulatory records.
  • Assist with submission scheduling.
  • Perform regulatory intelligence
  • Contribute to the drafting, review, and quality assessment of regulatory documents.
  • Contribute to the development of regulatory team processes and best practices.
  • May be assigned as regulatory liaison for development teams (attend meetings, provide guidance to teams, report activity to regulatory management)


Education, Experience, and Skills:

  • Bachelor’s degree or higher
  • At least 1+ years experience in regulatory affairs or equivalent work experience
  • Basic understanding of global drug development regulations & guidance documents
  • Basic familiarity with the Common Technical Document format
  • Experience with WORD, EXCEL, and electronic document management systems
  • Able to establish and maintain positive and productive relationships.
  • Strong and clear communication skills
  • Quickly learns new skills and acquires knowledge.
  • Solid analytical, negotiations, and problem-solving skills
  • Understands the need to maintain very high-quality standards during drug development.
  • Is driven by a commitment to patients, and appreciation of clinical trial participants.


Chinook is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported.  We respect and value different experiences and viewpoints.  We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

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  • Location
    Oakland, California
  • Department
    Regulatory Affairs (800)
  • Employment Type
    Full-Time
  • Minimum Experience
    Entry-level