Chinook Therapeutics

Director, Regulatory Affairs CMC

Regulatory Affairs (800) · Seattle, 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 Director, Regulatory Affairs CMC will be responsible for CMC-related submission planning and collaboration with subject matter experts to ensure high‑quality submission documents in a timely manner. This position provides leadership, direction, and interpretation of technical information to support product development through effective processes and implementation of regulatory strategies. This position will report to the Sr. Director, Regulatory Affairs CMC.

Responsibilities include:

• Serve as an independent CMC Regulatory Affairs lead on global project teams and as a subject matter expert in CMC Regulatory Affairs for small molecule drug substance and drug product manufacturing, global submissions, etc.
• Partner with cross functional teams to gain alignment on submission planning.
• Responsible for ensuring the appropriate execution and collaboration of CMC regulatory strategy.
• Provides strategic guidance regarding global regulatory requirements/regulations to internal stakeholders.
• Lead the preparation of risk assessments to regulatory filings on CMC topics.
• Actively seek and exercise judgment on complex issues, guided by a thorough understanding of phase appropriate CMC requirements/regulations.
• Understands probabilities of technical success for the solutions.
• Builds and manages relationships through active partnering with key internal and external stakeholders.
• Support regulatory submissions (IND, IMPD, NDA, MAA, etc.), briefing documents, response documents for health authority interactions and address questions/requests, as well as an annual update (e.g. DSUR, IB).
• 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 on-site at any Chinook office or remote (within US or Canada). Preference given to candidates located in the greater Seattle, Vancouver, or San Francisco Bay areas.

Education, Experience, and Skills:

Required

• BS degree in Life Sciences or related field.
• 12+ years direct experience in biotech and or Regulatory Affairs or in lieu of experience, education may be deemed appropriate.
• Ability to influence the development of overall corporate objectives and long range goals.
• Experience in drug development, market applications and commercial lifecycle.
• Excellent organizational skills with a high level of accuracy and detail orientation.
• Collaborative team player who has the ability to think and act quickly and identify creative solutions to complex problems.
• Proficient knowledge of MS Office.
• Previous experience leading CMC regulatory meetings with Health Authorities.

Preferred:

• Comfortable in a fast-paced small company environment with minimal direction and able to be flexible.
• Must have critical thinking skills, robust technical writing skills, strong scientific skills, good interpersonal communication skills.
• Leadership skills, and ability to inspire colleagues.

Salary Range: $208,000 - $243,000

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: 03/25/2023