Chinook Therapeutics

Manager, Regulatory Affairs

Regulatory Affairs (800) - Remote, Washington

Company:

Chronic kidney diseases are a severe and growing worldwide problem with a lack of effective treatments often leading to dialysis, transplantation, and high costs to health care systems. Up to 10% of the global population suffers from kidney disease and in the U.S. alone, kidney diseases account for over $130 billion in annual costs.

At Chinook Therapeutics our purpose is to discover and develop precision therapies to preserve kidney function and make dialysis and transplant unnecessary for people living with kidney disease. We strive for excellence in all we do and think big in our innovation; our highest priority is to do the right thing for patients while working together and having a whole lot of fun!

Our pipeline of precision medicines targets rare, severe kidney disorders with few currently approved therapies. For more information on Chinook and our pipeline, check out our site www.chinooktx.com/about & www.chinooktx.com/pipeline. We trade on Nasdaq under the ticker symbol KDNY and are headquartered in Seattle, WA with offices in Vancouver, BC, and Oakland, CA.

We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. We are building a diverse and inclusive workforce –come and be a part of our growth.

At Chinook, we are building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate is not exactly as we describe it here.

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 Senior or Executive Director, Regulatory Affairs.

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 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.
• Various other tasks as necessary for the position based on manager’s discretion.
• Contribute to and participate in the development and maintenance of a positive team-focused company culture.

Location:

Chinook has offices located in Seattle WA, Oakland CA, and Vancouver BC

• This position may be located at any Chinook office location or remote (within US or Canada) with preference given to candidates located in the vicinity of a Chinook office.

Education, Experience, and Skills:

Required

• BS/MS degree in a life science or a related field.
• 6+ 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.

Preferred:

• 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.

Salary Range: $144,000 - $168,000

Benefits:

• Paid parental leave
• Vacation and Sick time
• Living organ donor leave
• Volunteer time off
• 15 Paid Holidays
• Hybrid Work
• Flexible scheduling
• Healthcare plans
• Retirement Matching
• Financial wellness programs
• Employee assistance programs (EAPs)
• Internal learning & development courses

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.

To Apply:

Chinook Therapeutics

Chinook Therapeutics is an Equal Opportunity Employer

Submitted: 01/25/2023