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
- ...Vacation, Holidays, and Sick Leave. Employee Assistance Program, Generous Employee Referral Program and more. POSITION SUMMARY The Executive Director holds full accountability for overseeing all community operations and ensuring the quality of care and services provided....SuggestedWork at officeLocal areaWeekend workAfternoon shift
Cogir USA
Spokane, WA18 hours 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...Suggested
Confidential
Spokane, WA3 days ago - ...program by: Providing input and direction to the program director as he/she manages the day-to-day operations of the program... ...Mandated Reporting training once every 3 years Be diligent in executing the T-Minus Plan prior to launch Actively participate in the...SuggestedLocal area
LifeWise Academy
Spokane, WA3 days ago - ...supply chain, business development, customer relationships, human resources, and financial performance. This role demands a senior executive with a strong background in aviation, particularly as an experienced pilot, and a proven track record in leading complex, safety-...Suggested
Confidential
Spokane, WA4 days ago - ...Managing Director, Major Gifts About the Company Pioneering organization advancing the Technion-Israel Institute of Technology... ...CRM systems, is highly valued. Hiring Manager Title Chief Executive Officer (CEO) Functions ~ Non-Profit Management...SuggestedLocal area
$92.23k - $147.48k
...powered advice on this job and more exclusive features. Join us to create the best life for yourself and our residents! As the Executive Director, you are responsible for leading the day-to-day operations of the community, including service provision, financial, human...Full timeTemporary workWork experience placementWork at officeLocal areaFlexible hours$75k - $85k
...Chief Development Officer (CDO) you’ll be a visionary and strategic leader, serving as a key partner to the Chief Executive Officer (CEO) and Board of Directors. In this role you’ll drive the growth and sustainability of Habitat for Humanity-Spokane by leading fundraising...Work at officeFlexible hoursHabitat for Humanity-Spokane
Spokane, WA4 days ago$83.25k - $138.55k
...Distribute workload appropriately. Motivate and empower team members. Develop team members including, but not limited to, creating, and executing individual development plans. Train and mentor team members in root cause analysis and PDCA. Work with team members to identify...Permanent employmentTemporary workFor contractorsParker Hannifin Corporation
Spokane, WA4 days ago$77.97k - $109.02k
Quality Assurance Manager We are Lennar Lennar is one of the nation's leading homebuilders, dedicated to making an impact and creating an extraordinary experience for their Homeowners, Communities, and Associates by building quality homes and providing exceptional...For contractorsLive inWork at officeLocal areaLennar
Spokane, WA4 days ago- ...and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Accommodations Maximus provides reasonable...Minimum wageContract workTemporary workWork experience placementWork at officeHome office
MAXIMUS
Spokane, WA3 days ago - ...0% direct primary care. The CMO works closely with the Clinic Director to achieve organizational goals, improve clinic performance, strengthen... ...care models. Ability to work collaboratively with executive leadership, clinic leadership, providers, clinical staff, and...
Native Project
Spokane, WA3 days ago - ...Business Partner Marketing Manager in Spokane, WA to drive grassroots growth by connecting with medical providers. You will create and execute marketing initiatives, referral programs, and communications tailored to Personal Injury law, building a strong network and brand...Work at officeLocal area
Swapp Law
Spokane, WA1 day ago - Lennar is seeking a Land Acquisition Manager to help identify land, lots, and development opportunities in the Spokane Valley area. You will oversee due diligence, coordinate with the VP of Land, and participate in meetings with brokers, landowners, and officials to advance...
Lennar
Spokane, WA3 days ago - Job Description Job Description GeoSearch is actively seeking a Survey Party Chief to join our client's Spokane, WA office. This role involves managing a survey crew or working independently to perform boundary, topography, ALTA, right-of-way, and construction surveys...Work at officeFlexible hours
- Job Description Job Description Benefits: Dental insurance Employee discounts Free food & snacks Health insurance Opportunity for advancement Job Summary Responsibilities Develop and maintain professional functional working relationships with...Hourly payLocal areaFlexible hoursNight shift
$175k - $275k
...Description: VP of Product – BuyWander Build the Most Fun Way to Shop on the Internet Location: Seattle, WA Type: Full-Time | Executive Compensation: Competitive Salary $175-275K includes Meaningful Equity + Performance Bonuses ABOUT BUYWANDER BuyWander...Full timeLocal area- ...leadership team, providing clinical and administrative direction to all medical and clinical services staff, and collaborating with executive and senior leadership teams to meet organizational goals. The role also involves strategic planning, program development, and the...
Confidential
Medical Lake, WA4 days ago $310k - $350k
...appropriate use of resources, and designating staff assignments to meet the goals of ESH. Strategic Partner: Collaborate with executive and senior leadership teams to meet organizational goals and to optimize processes and services delivered. Perform leadership and...Work at officeTEEMA
Medical Lake, WA2 days ago- Job Description Job Description This position is CONTINGENT on contract award . This position will work at the Fairchild AFB outside of Spokane, WA. We offer a strong benefits package and highly competitive wage. The Aircraft Mechanic II – APG / Crew Chief performs...Contract workLocal area
- ...collaborative, inclusive, and psychologically safe environment. In this executive-level role, you will be the primary architect of clinical... ...to subordinate physicians and professional service staff. Regulatory Stewardship: Ensure the medical department remains in full...Work at office
$69.2k - $86.5k
...in 1990, WWT is a global technology solutions provider leading the AI and Digital Revolution. WWT combines the power of strategy, execution and partnership to accelerate digital transformational outcomes for organizations around the globe. Through its Advanced Technology...Full timeRemote workShift workWorld Wide Technology
Spokane, WA3 days ago$2,500 per week
Financial Highlights - Enjoy an Immediate Pay Raise and Professional Growth! $10k Fast Start Bonus Per Month for 12 months, $120k First Year, requires one new commercial account with at least 250 employees, every two weeks. $2,500 First Week Training Pay for the first five...Currently hiringImmediate startDay shift- ..., direct investment, and a strong culture of promotion from within. Key Responsibilities Direct and mentor the sales team to execute targeted outreach, developing new commercial and residential business opportunities. Partner with executive leadership to develop...For contractorsSummer workLocal areaImmediate start
- Job Description Job Description Description: This position is contingent upon contract award. Resicum International LLC is seeking experienced Aircraft Mechanic II – APG/Crew Chiefs to support the KC-135 Contractor Field Team (CFT) Support Services program...Full timeContract workFor contractorsWorldwide
- Job Description Job Description Aircraft Mechanic II - APG Crew Chief Job Description ACET is seeking Aircraft Mechanic II - APG Crew Chief at our Fairchild AFB WA location. Responsibilities: Aircraft Mechanic II - APG Crew Chief must have a combination...For contractors
- ...Summary The Chief Medical Officer (CMO) is a senior physician executive who provides visionary leadership, clinical oversight, and... ...and medical services to ensure exceptional patient outcomes, regulatory compliance, and operational excellence. Working closely with executive...Flexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
