Director, Regulatory Affairs
Confidential
Executive Director, Regulatory Affairs
About the Company
Esteemed company developing medicines for inflammatory & autoimmune diseases
Industry
Biotechnology
Type
Privately Held, VC-backed
Founded
2018
Employees
51-200
Funding
$101-$200 million
Categories
- Biotechnology
- Life Science
- Therapeutics
Specialties
- cell therapy
- autoimmune
- and lupus
- lupus
- multiple sclerosis
- systemic sclerosis
- scleroderma
- myasthenia gravis
- car t-cell
- and stiff-person syndrome
About the Role
The Company is seeking an Executive Director for Regulatory Affairs to provide strategic and operational leadership across its cell therapy portfolio. The successful candidate will be responsible for defining and executing global regulatory strategy to support the development, registration, and commercialization of advanced therapies, with a focus on commercial readiness, labeling strategy, and health authority engagement. This role requires a seasoned regulatory leader with deep experience in advanced therapies, capable of shaping regulatory strategy from early development through approval and launch, and partnering closely with cross-functional teams. The Executive Director will also be the primary interface with global health authorities, including the FDA, and will lead and support key regulatory meetings and negotiations. Applicants must have a Bachelor's degree in a scientific discipline (advanced degree preferred) and at least 15 years of progressive regulatory affairs experience in the pharmaceutical or biotechnology industry, with a significant background in advanced therapies. Experience in cell and/or gene therapy, particularly in the context of autoimmune diseases, is highly preferred. The role demands a proven track record in leading global regulatory strategies, including BLA/MAA experience, and a strong understanding of labeling strategy development and negotiation. Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks is essential, with a preference for candidates with EMA and ex-US experience. The ideal candidate will have strong executive communication skills, the ability to influence senior leadership, and a strategic mindset that balances scientific rigor, regulatory compliance, and commercial impact.
Hiring Manager Title
SVP, Chief Regulatory Officer
Functions
- Legal
- Operations
- ...Executive Director, Regulatory Affairs About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases Industry Biotechnology Type Privately Held, VC-backed Founded 2018 Employees 51-200 Funding...Suggested
Confidential
Everett, WA5 days ago $111.5k - $131.2k
...by new and exciting growth opportunities and at a rapid pace. Below are details on an open job. We are looking for a Manager, Regulatory Affairs who will join our team in Marysville, OH. The Manager, Regulatory Affairs will oversee the strategic development and...SuggestedRemote workShift workHawthorne Gardening Company
Marysville, WA10 hours ago- ...independently while leading teams tasked with performing detailed Root Cause Corrective Action (RCCA) investigations related to regulatory compliance issues. This activity enables program and functional leadership to understand the systemic root causes of compliance issues...SuggestedContract workWork experience placement
ACL Digital
Everett, WA5 days ago - The Annual Giving Officer provides a range of services for fund development; focuses on, but not limited to, Managing the Annual Fund and Sponsorship programs, and Overseeing donor cultivation and stewardship activities/events. Providence caregivers are not simply ...SuggestedMinimum wageFull timeLocal areaShift work
$77.97k - $90k
...regarding compliance items, including current SOPs, revised SOPs or policies, and new policies or procedures. Stays well-informed on any regulatory changes and cascades the information to location(s) supported. Responsible for due diligence of our Third-Party Risk Management...SuggestedFull timeLocal areaImmediate startShift workDay shift- The Senior Manager, Global Tax Planning leads and supports U.S. federal and international tax planning, with a primary focus on corporate restructuring, tax basis studies, and the application of the U.S. consolidated return regulations. This role will partner with M&A, ...Work at officeLocal areaRelocation
$192.36k - $351.78k
...A technology innovation leader in Everett, WA, is seeking a Senior Director to oversee strategic planning and portfolio management in the RF test and measurement sector. The ideal candidate will have extensive experience in product management and a strong track record...Keysight Technologies
Everett, WA5 days ago$22 - $26 per hour
Valence is seeking a Quality Assurance Administrator in Everett, WA (1st shift, 6am-2:30pm). Compensation ranges from $22.00 to $26.00 per hour (DOE). This on-site role reports to the Quality Manager and focuses on QA systems, SOP development, internal audits, and process...Hourly payWork at officeDay shift- Reporting to Fortive's FP&A Senior Director, the FP&A Senior Manager supports the enterprise-wide FP&A function, serves as a finance partner to corporate functional leaders, and operates the planning, forecasting, analysis, and reporting cadence for corporate finance,...Local areaShift work
- ...shift, every day. The role ensures that all materials and finished products are safe and conform to all relevant specification, regulatory and customer requirements. Customers, Regulators and our QA Leadership ensure we ‘do the right things’ to produce safe, quality food...Work at officeAll shiftsShift workWeekend work
Kettle Cuisine
Everett, WA1 day ago - ...The University of California seeks a Director for its Title III grant fund, focusing on transformative changes to support low-income students. This position involves leadership, management, and oversight of grant-related initiatives. Qualified candidates will hold a Bachelor...
University of California
Everett, WA4 days ago $160.1k - $297.8k
...A global technology corporation in Everett is looking for an HR Director to shape the future of their people and culture. This pivotal role involves driving organizational strategy, enhancing workforce management, and fostering a high-performance culture. Candidates should...Fluke Corporation
Everett, WA4 days ago$24 per hour
...Ability to identify and create processes and write procedures Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community Thrives in a challenging, entrepreneurial atmosphere; open to change and creating...Hourly payMinimum wageFull timeLocal areaShift workWeekend workDay shiftKettle Cuisine
Everett, WA5 days ago$47.05 - $73.04 per hour
...balanced portfolio of donors to solicit major and annual gifts, collaborating with ministry staff, board volunteers, and the Executive Director Foundation/Ministry CPO. This role involves nurturing mid-range donor relationships through personal interactions and written...Minimum wageWork from homeShift workProvidence Swedish Medical Center
Everett, WA3 days ago$725 per month
...family engagement and connection, financial performance, and regulatory compliance. Creates and executes the business plan and develops... ...to raise community profile. Becomes active in social and civic affairs of the local community that align with the Company's mission....Hourly payFull timeTemporary workPart timeLocal areaFlexible hoursShift workNight shiftAfternoon shiftBrookdale Senior Living
Everett, WA5 days ago- ...with the completion of launch steps 8-10 and operation of the live program by: Providing input and direction to the program director as he/she manages the day-to-day operations of the program Assisting with the 5 L's of operations: Leadership: Recruit and...Local area
LifeWise Academy
Everett, WA2 days ago $725 per month
...family engagement and connection, financial performance, and regulatory compliance. Creates and executes the business plan and develops... ...to raise community profile. Becomes active in social and civic affairs of the local community that align with the Company’s mission....Hourly payFull timeTemporary workPart timeLocal areaFlexible hoursShift workNight shiftAfternoon shiftBrookdale
Everett, WA2 days ago- ...Executive Director About the Company Well-established cancer research fund Industry Financial Services Type Non Profit Founded 2015 Employees 1-10 About the Role The Company is seeking an Executive Director to lead its...
Confidential
Everett, WA2 days ago $83.25k - $102.26k
Overview Crane Aerospace and Electronics has an exciting opportunity for an Import Compliance Analyst at our Lynnwood, WA location. Crane Aerospace & Electronics supplies critical systems and components to the aerospace and defense markets. Located in the epicenter of ...For contractorsWork experience placementWork at officeLocal areaCrane Aerospace & Electronics
Lynnwood, WA4 days ago- Duties You will provide oversight for implementing and validating new or revised programs; establish acceptable parameters, and reviews management implementing principles. You will review programming documents received from higher headquarters (HHQ) to determine effect...Full timePart timeInterim roleWork at officeLocal areaImmediate startRemote workRelocationRelocation package
U.S. Pacific Fleet
Everett, WA4 days ago - ...Managing Director, Major Gifts About the Company Pioneering organization advancing the Technion-Israel Institute of Technology Industry Fund-Raising Type Non Profit Founded 1940 Employees 51-200 Categories Association...Local area
Confidential
Everett, WA5 days ago - Corrections Officer Come work for a city where the community and leadership support Law Enforcement! Lateral Incentive Bonus up to $5,000! Educational Incentive Pay, Longevity YOU MUST attach certificates or transcripts to your application as proof of completion ...Permanent employmentFull timeShift workNight shift
City of Marysville, Washington
Marysville, WA5 days ago - Brookdale Senior Living is seeking a Community Operations leader in Everett, WA. This role oversees the community’s daily operations, resident engagement, and financial performance, while working with the district team to grow occupancy and ensure high-quality resident...
Brookdale Senior Living
Everett, WA5 days ago - **Crane Aerospace and Electronics** has an exciting opportunity for an **Import Compliance Analyst** at our **Lynnwood, WA**location.**Job Summary:** The Import Compliance Analyst (ICA) supports the site’s import compliance program, with direction from the Group/Site Export...Work experience placementLocal areaFlexible hours
Crane Co.
Lynnwood, WA2 days ago $105k - $130.5k
Description Funko Overview Welcome to the Funko-verse, a world built on pure imagination, a land governed by the philosophy that stories matter, a universe comprised of characters from countless fandoms, a galaxy of once upon a times and happily ever afters. But what does...Local areaCerebras
Everett, WA1 day ago$162k - $192k
About HelionWe are a fusion power company based in Everett, WA, with the mission to build the world's first fusion power plant, enabling a future with unlimited clean electricity. Our vision is a world with clean, reliable, and affordable energy for everyone.Since Helion...Temporary workWork at office$147k - $220k
About HelionWe are a fusion power company based in Everett, WA, with the mission to build the world's first fusion power plant, enabling a future with unlimited clean electricity. Our vision is a world with clean, reliable, and affordable energy for everyone.Since Helion...Temporary workWork at office- ...SUMMARY The State and Local Tax Director is responsible for owning and leading all aspects of the Company's State and Local Tax... ...Monitor, interpret, and communicate state legislative and regulatory developments that may impact the Company. Conduct technical...Full timePart timeLocal areaRemote work
$85k - $95k
As a Hospice Community Liaison , you'll be the vital link between referral sources, patients, and our clinical team-ensuring seamless transitions and exceptional experiences. If you're passionate about connecting people to life-changing care, this is your opportunity...Flexible hoursPennant
Everett, WA5 days ago$75k - $90k
...Post-Acute Services Director At Genesis Healthcare, we are dedicated to improving the lives we touch through the delivery of high-quality care and exceptional service. As a leading provider in the long-term care industry, we believe in fostering a collaborative, inclusive...Temporary workLocal areaImmediate startGeneis Healthcare
Everett, WA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Regulatory Affairs. Be the first to apply!
