Executive 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
- ...serving as a cross-functional liaison, and working closely with the Director of Growth to drive the expansion of the expert community. The... ...setting direction and is equally adept at hands-on execution, and who can effectively engage with stakeholders across various...Suggested
- ...IL, GA, MD, VA, DC)Technical Summary:The Director, Marketing Compliance & Governance... ...wide marketing compliance, governance, and regulatory readiness programs, ensuring all marketing... ...channels and platforms.Reporting to the Executive Director, Marketing Operations & Administration...SuggestedWork experience placementFlexible hours
- Providence seeks an AVP of Control Tower and Inventory Strategy to lead an enterprise-scale, analytics-driven Control Tower for real-time visibility and predictive risk modeling across the healthcare supply chain. You will define operating models, governance, KPIs, and...Suggested
Providence Service
Renton, WA1 day ago - ...Project ExecutiveThe Project Executive leads and manages a business unit responsible for profit and loss aligned with overall company business plan. The Project Executive role has overall accountability for insuring construction projects are performed in a safe and effective...SuggestedContract workFor contractorsFor subcontractor
EC Electric
Renton, WA3 days ago - ...strategic leader with a proven track record in communications, public affairs, and a deep understanding of how to influence and elevate an... ...advisor, with the ability to work closely with the CEO and executive team to elevate the organization's and the CEO's voice. The role...SuggestedLocal area
- Job SummaryThe Sr. Vice President, Valuation is responsible for independently preparing market value appraisals for commercial real estate and other properties, preparing appraisal reports, keeping up to date on real estate market, and mentoring trainees. Decisions are ...TraineeshipWork at officeLocal area
- ...State Market Job Summary:The VP, Public Affairs Markets Outside California serves as the... ...engagement, local government relations, executive positioning, and issues management.Reporting... ..., Advocacy, Marketing, Legal, Policy & Regulatory Affairs, and Community Health.Internal...Local areaShift work
- ...segment within National Accounts, ensuring strong operational execution, sustained growth, and alignment with enterprise priorities.This... ...ManagementJob Type: StandardSchedule: Full-timeJob Level: Director/Senior DirectorTravel: Yes, 20 % of the TimeEmployee Status: RegularContract workRemote work
$253k - $312.5k
...Your Hope. Your Cure. POSITION SUMMARY The Senior Director, Regulatory Affairs reports to the Head of Regulatory Affairs and is responsible... ...a critical role in regulatory strategy, study design, execution, and in leading regulatory interactions. The ideal candidate...WorldwideUmoja Biopharma
Seattle, WAmore than 2 months ago- Providence Health Plan Group in Renton is seeking a Chief Source to Settle Officer responsible for system-wide procurement and accounts payable activities. The role drives operational excellence and compliance, ensuring efficient management of Source-to-Settle processes...
Providence Health Plan Group
Renton, WA4 hours ago $131.52k - $237.36k
...coaches. That’s how we’re UNSTOPPABLE for our employees!The Senior Executive Strategy & Planning Manager is a key member of a senior... ...owns creation of high-visibility content, including Board of Directors presentations, and executive-level materials reviewed by the CEO...Full timeTemporary workPart timeWork experience placementWork at officeLocal areaFlexible hours$108k - $216k
...Develop and manage legislative assessment strategies, forecasting regulatory trends and conducting gap analyses.Serve as subject matter... ...issues, coordinating research and stakeholder engagement.Drive execution of business plans by identifying needs, removing obstacles,...Full timeTemporary workPart time$172.5k - $222.5k
...responsible for: Circle is looking for a Senior Manager to join the Regulatory Assurance team who will help to create a central global... ...results. What you'll work on: Driving the strategy, framework, and execution of the Regulatory Change Management Program.Identifying and...Flexible hours$107.7k - $145.4k
...for developing sanctions related guidance and SOPs according to regulatory requirements and to mitigate compliance risk. The candidate... ...establishing successful partnerships with internal and external teams to execute tactical initiatives or equivalent- Experience with research...Flexible hours- ...Juris Doctor preferred8+ years professional experience in legal, regulatory, compliance environments; attorneys with “Big Law” and/or in... ...by amplifying integrity and effectively managing concerns.Your role reports to the Director of Ethics in Allegations Management.ApprenticeshipWork at office
- ...Executive Director, Lifecycle Lead 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...
- ...Accountabilities Procurement Operations Ensure efficient execution of sourcing, contracting, and purchasing processes across all... ...categories. Maintain compliance with organizational policies, regulatory requirements, and ethical standards. Drive supplier...
Providence
Renton, WA4 hours ago - ...Vice President, Public Affairs About the Company Ambitious healthcare management organization Industry Hospital & Health... ...community affairs, stakeholder engagement, local government relations, executive positioning, and issues management. As the primary Public...Local area
- Pacific Medical Centers seeks a Manager Information Security to lead the security team in Renton, WA. The role manages daily operations, prioritizes workload, and guides policy development while ensuring HIPAA/DIACAP compliance. This full-time day position requires ...Full time
Pacific Medical Centers Corp
Renton, WA3 hours ago - ...customer and consumer needs, and how growth choices translate into execution across marketing, sales, operations, technology, and talent.... ...for quality and commercial outcomes.The WorkAs an Associate Director, you will lead CEO- and C-suite-level strategy and reinvention...Full timeLive inWork at officeLocal area
$120.5k - $180.7k
At Wizards of the Coast, we connect people around the world through play and imagination. From our genre-defining games like Magic: The Gathering and Dungeons & Dragons to our growing multiverse, we continue to innovate and build new ways to foster friendship and connection...Seasonal workShift work- ...activities are effective and aligned across the organization. This executive will provide strategic direction to the compliance function,... ..., and oversee all aspects of compliance, including managing regulatory exams, audits, and reporting. The role also involves...
- ...Vice President, Executive Search & Business Development About the Company Nationally recognized executive search firm Industry Staffing and Recruiting Type Privately Held Founded 1979 Employees 1-10 Categories Consulting & Professional Services...
- ...Chief Physician & Transformation Executive About the Company Non-profit Catholic healthcare system Industry Hospital & Health Care Type Non Profit Founded 2016 Employees 10,001+ Categories Health Care Health & Wellness Health Systems...
$145.48k - $183.51k
Consulting Director, Regulatory Analyst (Utilities/Power/Renewables)Are you ready to lead transformative environmental projects that power... ...solutions that advance objectives on the ground or at the executive level. Please submit your resume and brief cover letter. ERM...Full timeContract workFixed term contractCasual workWorldwideFlexible hours$154k - $189k
...Description Senior Managing Policy Director Position Open Until Filled... ...priorities. Manage the execution of campaign strategy and... ...collaboration with the Legislative Affairs Department, lobbies elected... ...policy advocacy letters and regulatory comments. Analyzes...Full timeTemporary workWork experience placementWork at officeRemote workWork from homeHome officeFlexible hoursWeekend workAfternoon shift2 days per weekACLU of Washington
Seattle, WA9 days ago$114.3k - $235.32k
About Pinterest:Millions of people around the world come to our platform to find creative ideas, dream about new possibilities and plan for memories that will last a lifetime. At Pinterest, we’re on a mission to bring everyone the inspiration to create a life they love,...Work at officeLocal areaRemote workRelocation package- ...ERM is seeking a Consulting Director, Power, Energy & Regulatory Advisory to join our Capital Project Delivery team. You will lead environmental permitting and CEQA/NEPA efforts for major power, transmission, and renewables projects, with a focus on California markets...
ERM
Seattle, WA4 hours ago - ...role is focused on amplifying the CEO's and SLT's effectiveness, particularly in the areas of time management, decision-making, and execution. The successful candidate will be a trusted partner, gatekeeper, and execution lead, with a strong background in digital and e-...
$180k - $230k
..., the Museum fosters cross-cultural understanding that advances racial and social equity.The Leadership Opportunity The next Executive Director of The Wing Luke Museum will step into a moment of extraordinary significance and opportunity. Reporting to the Co-Presidents...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
- financial executive Renton, WA
- senior manager executive compensation Renton, WA
- chief dental officer Renton, WA
- information technology executive Renton, WA
- store executive Renton, WA
- nonprofit board member Renton, WA
- president Renton, WA
- chief executive officer ceo Renton, WA
- change management executive Renton, WA
- college president Renton, WA