Manager, Regulatory Affairs (Small Molecules)

Regulatory Affairs (800) · Seattle, Washington
Department Regulatory Affairs (800)
Employment Type Full-Time
Minimum Experience Experienced

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 1/2 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: 


The Manager, Regulatory Affairs will be responsible for acting as the regulatory representative on study teams and provide oversight for global development, implementation and execution of regulatory strategies for investigational programs, through to and eventually beyond marketing applications.  This role will report into the Executive Director, Regulatory Affairs and can be based in Seattle, Oakland or remote.  


Responsibilities include:

 

  • Advising on the context and applicability of functional regulatory requirements for each assigned program appropriate to the stage of product development
  • Coordinating the drafting, editing and preparation of regulatory submissions
  • Ensuring the content and accuracy of regulatory fillings
  • Overseeing and ensuring that the regulatory files and systems are maintained in accordance with department procedures, compliance standards, laws, and regulations
  • Serving as the regulatory representative at project meetings and interacting with cross-functional partners in order to achieve common goals
  • Managing regulatory tasks within time and budget for approved project plans
  • Communicating project status and issues
  • Supervising the activities of regulatory associates and assistants


Education, Experience, and Skills:


  • BS/MS degree in a life science or a related field
  • 5-7 years of regulatory affairs experience
  • Demonstrated knowledge of regulatory guidelines and regulations
  • Drug development process knowledge
  • Demonstrated ability to lead and manage projects
  • Strong analytical and problem-solving skills
  • Excellent organizational skills with a high level of accuracy and detail orientation
  • Advanced computer application skills in MS Office and Adobe Acrobat
  • Demonstrated ability to handle multiple competing priorities, prioritize multiple tasks, and utilizing resources effectively
  • A demonstrated ability to build and maintain positive relationships both internally and externally
  • Excellent interpersonal, verbal and written communication skills
  • Leadership qualities: ethics, integrity, creativity, collaboration, etc



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
    Seattle, Washington
  • Department
    Regulatory Affairs (800)
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced