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
- A leading HVAC company in Kent, WA is seeking a General Manager to oversee commercial HVAC operations. This role involves managing service, sales, installation, and financial performance to achieve growth. Candidates should have over 5 years of experience in the HVAC industry...SuggestedFull timeLocal area
Work With Your Handz
Kent, WA23 hours ago - InnVentures is seeking an Operations Manager in Training in Kent, WA, responsible for managing multiple departments and ensuring exceptional guest experiences. This position requires hands-on leadership and effective multitasking to support team goals. Qualified candidates...Suggested
InnVentures
Kent, WA2 days ago - ...Responsibilities Mentors General Managers to ensure successful operation of their hotels; sets short-term and long range goals in tandem with Executive Team and GM's to aid and achieve each property’s defined performance metrics. Ensures responsible financial management of assigned...SuggestedTemporary work
InnVentures IVI LP
Kent, WA1 day 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
Kent, WA4 days ago - ...Managing Director, Major Gifts About the Company Pioneering organization advancing the Technion-Israel Institute of Technology... ..., is highly valued. Hiring Manager Title Chief Executive Officer (CEO) Functions ~ Non-Profit Management...SuggestedLocal area
Confidential
Kent, WA2 days ago $250k
Overview Position Summary : The Enterprise Solutions Executive is responsible for driving strategic sales initiatives within assigned geographies for the Equipment Value Management Business Unit. This role focuses on growing new business opportunities and retaining/protecting...Contract workLocal area$250k
For our client, we are seeking an Enterprise Solutions Executive to join the team of a leader in the Healthcare space. This role will support revenue growth through customer focus, relationship development, and disciplined commercial execution. You will collaborate with...Contract workVisa sponsorship- Quality Assurance Manager Responsible for the daily operation of the Quality Assurance team and activities, makes work assignments as needed to meet production and Program Participant needs. Nonconformance and Corrective action process. Internal Auditing program. Preventive...Permanent employment
Orion Industries
Auburn, WA3 days ago - Muckleshoot Casino Resort in Auburn, WA seeks an experienced VIP Host to cultivate relationships with high-value gaming guests, drive enrollment into the Players Club, and coordinate exclusive events and client experiences. You will manage personal client preferences, ...
Muckleshoot Casino
Auburn, WA1 day ago $80k
...Time Operations Manager for our Kent, WA location. Responsible for overseeing daily warehouse operations, ensuring compliance with regulatory requirements and operational efficiency, the role involves leading a team and managing resources effectively. The ideal candidate...Full timeACT 2 Services, Inc.
Kent, WA4 days ago$85k - $105k
...slow-moving, or aging inventory. Serve as the primary escalation point for complex inventory planning issues. Inventory Strategy & Execution Translate business objectives into effective inventory planning strategies and team priorities. Coordinate planning for seasonal...Full timeSeasonal workSmartTalent Staffing and Recruiting
Auburn, WA2 days ago- 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...
Providence Service
Renton, WA2 days ago $196.98k - $325k
...from you. Role Summary The Managing Director Technical Operations Planning sets the... ...maintenance, continuous improvement and execution of: All maintenance planning activities... ...our career site and view benefits. Regulatory Information Equal Employment Opportunity...Full timeTemporary workFor contractorsLocal areaShift workAlaska Airlines
Seatac, WA23 hours ago$168.77k - $236.28k
...housing development portfolio, driving the vision, planning, and execution of multifamily housing and redevelopment initiatives from... ...structuring and delivering multifaceted development deals, navigating regulatory environments, and leveraging diverse financing tools to...Housingconsortium
Tukwila, WA1 day ago- ...long-range planning to ensure the institution's sustainability and success. The President will work collaboratively with the Board, executive cabinet, faculty, staff, and external partners to identify opportunities for innovation, revenue growth, and operational...
Confidential
Des Moines, WA2 days ago - ...Our client is seeking a visionary and mission-driven Chief Executive Officer (CEO) who emphasizes relational leadership to guide the... ...initiatives. The CEO will be expected to work closely with the board of directors to execute pivotal strategies while also engaging with key...Remote work
Confidential
Maple Valley, WA2 days ago - ...Chief Executive Officer (CEO) About the Company Mission-driven organization providing supportive services to single parents &... ...upholding strong governance in partnership with the Board of Directors. They will also be tasked with leading fundraising efforts, building...
Confidential
Maple Valley, WA3 days ago $100k - $110k
...abatement projects from initial assignment through final completion. This position provides leadership to field personnel, ensures regulatory compliance, manages project profitability, maintains exceptional customer service, and develops the abatement division for long-...Full timeFor contractorsFor subcontractorWork at officeLocal area$170k - $225k
...The 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 manner. This...Full timeContract workFor contractorsFor subcontractorFlexible hoursEC Electric
Renton, WA4 days ago$120.86k - $193.37k
Job Description Position Profile The Assistant Police Chief is a non-civil service appointed position and reports to the Chief of Police. The Assistant Chief will assist in the planning and administration of the Police Department, as well as its policies and operations...City of Fife
Fife, WA4 days ago- #J-18808-LjbffrFull time
Providence
Renton, WA23 hours ago - ...Calling all Esteemed Leaders! Are you a senior nursing executive who thrives in dynamic environments, leading transformation, strengthening... ...patient care standards as established by accreditation, regulatory and quality agencies. Ensure compliance with the State Nurse Practice...Contract workInterim roleLocal area
Providence Service
Renton, WA21 hours ago $190k - $210k
...enjoy using your construction and organizational skills, then we have a role for you! Potelco, Inc. is seeking an experienced Project Executive to join the team on a project in Modesto, California. The Project Executive will provide overall senior leadership for large-scale...Ongoing contractContract workFor subcontractorLocal areaFlexible hours$165k - $225k
...operations including parts, service, warranty, technical support, and rebuild programs across multiple locations. • Develop and execute strategies to improve absorption rate, profitability, and recurring revenue growth. • Oversee shop and field service operations...Shift work$178.9k - $250.46k
...the ideal candidate's ability to serve our community and support our employees. The Vice President (VP) will report to KCHA's Executive Vice President of Administration/Chief Administrative Officer (EVP). This leader will be accountable for the efficiency and effectiveness...Full timeHousingconsortium
Tukwila, WA23 hours ago- The Quality Assurance Coordinator (“QAC”) is responsible for ensuring the effective implementation and oversight of client support planning and service delivery in alignment with Washington Administrative Code (WACs) and Supportive Living NW (“The Company”) policies and...
Supportive Living NW
Federal Way, WA21 hours ago - Quality Assurance Manager Harper Engineering Co. is seeking a detail-oriented, strategic Quality Assurance leader with expertise in AS9100/ISO9001 and FAA standards, who is committed to fostering ongoing enhancement and excellence in quality to join our team. Harper Engineering...Work at office
Harper Engineering Company
Renton, WA2 days ago - ...financial stewardship of comprehensive benefits, wellbeing, retirement, caregiver health, and absence programs. The role reports to executive leadership and guides a senior benefits team, collaborating with HR, Finance, Legal, Compliance, and Operations to ensure programs...Full time
Providence Health Plan Group
Renton, WA23 hours ago $111.9k - $167.9k
...streamlining existing QA workflows to ensure product integrity, regulatory compliance, and operational efficiency. The ideal candidate... ...external regulations, including audit readiness and successful execution of internal and third-party audits. • Drive risk assessment...Work at officeHasbro
Renton, WA2 days ago- ...interpret common information, reports and other documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or company representatives. Ability to effectively present information to management. PHYSICAL DEMANDS: The physical...Full timeWork experience placementWork at officeFlexible hours
National Beverage
Tukwila, WA4 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
