Top 9 Regulatory affairs manager Jobs in Bothell Wa

Manager, Regulatory Affairs
Jade Biosciences —Seattle, WA
- $135,000 - $150,000 a year
- Remote
- Microsoft Word
- 3 years
- Bachelor's degree
Quick Apply
TikTok Shop - External Affairs Manager
TikTok —Seattle, WA
- $103,360 - $209,380 a year
- 3 years
- Analysis skills
- Fair chance
- Paid parental leave
- Paid holidays
Economic Development Manager
Puget Sound Energy —Bothell, WA
- $82,000 - $136,300 a year
- 5 years
- Analysis skills
- Accounting
- AD&D insurance
- Paid holidays
11d
Business Program Manager, Legal Operations
Microsoft —Redmond, WA
- $77,800 - $169,900 a year
- Full-time
- Mid-level
- Finance
- Bachelor's degree
Director of Environmental Affairs
NorthStar Energy Shared Services —Seattle, WA
- $156,175 - $234,262 a year
- Full-time
- Engineering
- 11+ years
- Travel
- AD&D insurance
- Disability insurance
Sr Risk Mgr, Enviornmental Air/Water/Mobile Solutions Programs, Environmental Assurance & Protection
Amazon.com Services LLC —Bellevue, WA
- $109,000 - $163,900 a year
- Full-time
- Master's degree
- Presentation skills
- Bachelor's degree
- AD&D insurance
- Health insurance
Compliance Specialist, Product Compliance, AWS Global Trade & Product Compliance
Amazon Web Services, Inc. —Seattle, WA
- $102,000 - $178,400 a year
- Full-time
- PMP
- Master's degree
- Bachelor's degree
- AD&D insurance
- Health insurance
Project and Quality Manager II
Olympic College —Bremerton, WA
- $91,267 - $102,676 a year
- Online Application
- Background check
- Engineering
- University
- Paid holidays
- Disability insurance
Nuclear Siting Project Manager – Natrium Technology
TerraPower LLC. —Bellevue, WA
- $117,922 - $176,833 a year
- 8 hour shift
- Remote
- Engineering
- Master's degree
- 8 years
- Paid holidays
- Disability insurance
Quick Apply

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Katalyst Healthcares & Life Sciences —Bothell, WA
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Manager, Regulatory Affairs

Jade Biosciences
Seattle, WA

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Job Details

$135,000 - $150,000 a year

Qualifications

FDA submissions
Investigational new drug (IND) applications
Bachelor's degree
Regulatory submission editing and review

Full Job Description

About Jade Biosciences

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade's lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade's pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn.

Role Overview

The Regulatory Affairs Manager supports the development and execution of regulatory strategies to enable the successful development of biological products. This role is responsible for coordinating, compiling, and reviewing initial health authority submissions, as well as the preparation of timely, high-quality responses to health authority questions. The Manager ensures regulatory requirements are understood and incorporated into program activities while maintaining compliance with global regulations and internal standards. The Regulatory Manager will have recognition as a leading role in their assigned programs, and will work with support and guidance from senior regulatory management as needed.

Key Responsibilities

Drives timely submission of regulatory submissions including initial trial applications (e.g. IND, CTA) and marketing applications, and the documentation required to maintain these applications.
Draft, edit, and review regulatory documents such as meeting requests, query responses, and submission modules.
Conduct regulatory review of product documentation intended for submissions to ensure accuracy, consistency, and compliance with FDA and global regulations.
Participate in the review of key clinical and nonclinical documents (protocols, IBs, CSRs, DSURs, etc.) to ensure alignment with regulatory obligations and relevant guidelines (ICH, FDA, EMA, ROW).
Manage the processing, formatting, and operational aspects of regulatory submissions, ensuring compliance with regulatory requirements and internal quality standards.
Identify regulatory risks proactively and contribute to risk‑benefit assessments and mitigation strategies.
Maintain up‑to‑date knowledge of US and global regulations, guidance documents, and evolving regulatory expectations.
Monitor the external regulatory landscape and communicate potential impacts to internal stakeholders.
Support continuous improvement initiatives to enhance regulatory compliance, efficiency, and documentation quality
Provide regulatory input into clinical study planning and execution, including identification of regulatory requirements and expectations, as a member of operational study teams.

Qualifications

Bachelor's degree from an accredited institution required.

5–8+ years of pharmaceutical/biotech R&D experience, including 3–5+ years in Regulatory Affairs (or equivalent combination of education and experience). Small-midsize biotech experience highly preferred.

Strong ability to interpret scientific data and understand regulatory implications for biologics.

Direct experience supporting US regulatory submissions, including IND preparation or maintenance; experience with eCTD submissions required.

Experience contributing to or coordinating health authority submissions and responses.

Familiarity with ex‑US regulatory requirements preferred.

Solid understanding of US and global regulations and guidelines (21 CFR, FDA, ICH, GCP, GMP, eCTD).

Demonstrated ability to identify regulatory risks and support resolution strategies.

Strong organizational skills with the ability to manage multiple priorities and meet deadlines.

Excellent written and verbal communication skills, including the ability to clearly articulate regulatory positions.

Ability to work independently and collaboratively within a matrixed, multidisciplinary environment.

High proficiency in MS Word, Excel, Adobe Acrobat, and regulatory document management systems.

Position Location

This is a remote role; periodic travel to team and company events is required.

The anticipated salary range for candidates for this role is $135,000 - $150,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.

As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster.

Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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regulatory affairs manager jobs in bothell wa

Manager, Regulatory Affairs

TikTok Shop - External Affairs Manager

Economic Development Manager

Business Program Manager, Legal Operations

Director of Environmental Affairs

Sr Risk Mgr, Enviornmental Air/Water/Mobile Solutions Programs, Environmental Assurance & Protection

Compliance Specialist, Product Compliance, AWS Global Trade & Product Compliance

Project and Quality Manager II

Nuclear Siting Project Manager – Natrium Technology

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