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
- ...standards, establishing accountability, and driving a culture of compliance that extends to enterprise-wide privacy, cybersecurity, and regulatory change. Applicants must have at least 12 years' of progressive investment management compliance experience, with a strong...Suggested
- ...visible position demands a strategic thinker with exceptional project management skills, capable of serving as a trusted advisor to the executive team and ensuring the successful execution of the company's vision and strategy. Key responsibilities include acting as a...Suggested
- ...Clark County (RCCC) is looking for someone to join our team as Executive Director. RCCC is a non‑profit and part of a national network of... ...Monitor program activities and performance and ensure full regulatory and legal compliance in all operations. Coordinate the raising...SuggestedHourly payFull timeContract work
Recoverycafecc
Vancouver, WA2 days ago - David Evans and Associates, Inc. (DEA) Energy team seeks a Power Market Leader to drive the Power market strategy across the Pacific Northwest from Seattle, WA or Portland, OR. You will cultivate relationships with utilities and federal bodies, guiding pursuit strategies...Suggested
David Evans and Associates
Vancouver, WA5 days ago - ...Managing Director | WealthBridge Financial Group WealthBridge Financial Group is seeking an experienced and dynamic Managing Director... ...-performing teams, fostering strong client relationships, and executing strategic initiatives to drive business growth. As Managing Director...SuggestedVisa sponsorship
Wealthbridge-Financial-Group
Vancouver, WA1 day ago $220k - $255k
...being so you can provide exceptional care to others. As the Chief Executive Officer joining our team, you're embracing a vital mission... ...this role: Ensures compliance with all state, federal, and regulatory agencies. Ensures timely, relevant, and accurate financial...Full timeTemporary workPart timeWork at officeLifePoint Health
Vancouver, WA1 day ago- ...Chief Executive Officer (CEO) Vancouver, WA Must-Haves: Behavioral health leadership experience. Inpatient psychiatric leadership experience. Bachelor's degree in a clinical, financial or business related field. Nice-To-Haves: Prior inpatient...
Veracity
Vancouver, WA4 days ago $187.33k - $276.78k
...the operational activities of the Port, ensuring safe, efficient, compliant, and financially responsible execution of operations. The COO supervises the Director of Environmental Services, Director of Operations, Director of Facilities, Director of Engineering & Project...Full timeTemporary workWork at officeLocal areaFlexible hoursShift workADP
Vancouver, WA2 days ago$200k - $225k
...Job description Location : Remote Reports to : Chief Executive Officer (CEO) Salary : $200,000 - $225,000 Travel : Up to 25% Priority... ...Familiarity with federal grants compliance and multi-state nonprofit regulatory requirements Strong analytical, problem-solving, and decision-...Full timeContract workWork at officeRemote workHome officeGrabJobs
Vancouver, WA4 days ago- ...people strategy for a complex, multi-brand, multi-state organization at a pivotal stage of growth. You'll work directly alongside the executive team to build the culture, structure, and talent engine that allows InterDent to become the employer of choice across every market...
InterDent Service Corporation
Vancouver, WA1 day ago $118k - $138k
...programs/services and levels of care. The CCO executes strategic goals and program expansion in... ...the daily operations of programs, directors, and supervisors; oversees the development... ...and ensures compliance with all regulatory requirements, organization standards, policies...Full timeContract workTemporary workPart timeLocal areaImmediate startLifeline Connections
Vancouver, WA5 days ago- ...Chief Executive Officer (CEO) About the Company Leading healthcare provider with hospitals, physician practices & post-acute facilities... ...for ensuring compliance with all state, federal, and regulatory agencies, as well as providing timely and accurate financial information...Work at office
- ...trusted insight with expert guidance, Later removes guesswork from influencer marketing, enabling brands to choose the right creators, execute fully managed campaigns, and drive meaningful growth across awareness, engagement, and revenue. Trusted by leading enterprise...
Later
Vancouver, WA4 days ago - ...Executive Director About the Company Peer-led nonprofit organization empowering individuals and families through mental health and substance use recovery. Industry Non-Profit Organization Management Type Non Profit Employees 11-50 About the Role...
- ...Chief Executive Officer (CEO) About the Company Mission-driven organization providing support services to survivors of domestic... ...They will also be expected to work closely with the Board of Directors, staff, and community partners to ensure that the organization...Local area
$141.1k - $211.65k
This positionis responsible for managing a large project team/multiple project teams, or multiple small projects including staffing and performance appraisals. Serves as primary point of contact for project team(s). Provides project status updates to client and leadership...For contractorsWork at officeImmediate startFlexible hours$130k - $150k
...is proud to partner with Pier 360 in its search for its next Executive Director. ABOUT PIER 360 Founded in 1995 as Consumer Voices Are Born... ...Values. Ensure compliance with behavioral health licensing, regulatory requirements, contracts, and quality standards while promoting...Contract workWork at officeLocal area$200.24k - $353.5k
...oversee the clinical physics program, ensure the safe and effective delivery of radiation therapy services, maintain compliance with regulatory and accreditation standards, and partner closely with Radiation Oncologists, Radiation Therapists, Dosimetrists, and operational...Full timeWork at officeMonday to FridayFlexible hoursWeekend workPRISM Vision Group
Vancouver, WA3 days ago$194.19k - $277.41k
...exceptional Principal Program Manager to serve as a trusted, executive-level advisor to public agency clients. The role is expected to... ...and escalation across state DOTs, FHWA, FTA, USCG, and other regulatory bodies Lead and integrate large, multidisciplinary teams across...Full timeTemporary workPart timeFor contractorsWork at officeLocal areaHDR
Vancouver, WA1 day ago- ...Medical Physicist to lead clinical physics and dosimetry across multiple sites, ensuring safe, accurate radiation therapy delivery and regulatory compliance in a collaborative, patient-centered environment. The ideal candidate holds a Masters or PhD in medical physics, ABR...
US Oncology Network-wide Career Opportunities
Vancouver, WA5 days ago - ...construction, and specialty support services; advise on policy, regulatory, financial, and community dimensions; and steer large,... ...for the Pacific Northwest.The ideal candidate is a proactive, executive-caliber communicator with a proven record leading major corridor...Contract workWork at officeLocal area
HDR
Vancouver, WA1 day ago $297.86k
...trusting and collaborative relationships with medical staff leaders, directors, peers, and senior management to develop, sustain, and advance... ..., Chief Pharmacy Officer is accountable for: development and execution of pharmacy service strategy and tactics, system-wide pharmacy...$275k - $320.3k
...grantmaking. The programmatic areas of focus include: Arts & Culture Health Scientific Research Education Human Services As a member of the executive management team, the Chief Program & Impact Officer (CPIO) will report to and serve as a thought partner and collaborator with the...- A community-focused non-profit organization in Vancouver, WA is seeking an experienced Executive Director to oversee operations and fulfill its mission. The ideal candidate will have strong financial management skills, extensive nonprofit experience, and the ability to...
- ...multiple internal stakeholders. Strong technical and operational leadership skills are essential, as is the ability to build trusted executive relationships across product, engineering, and business leadership. The ideal candidate will have a deep understanding of...
- Vice President, Apps About the Company Global provider of high-quality hardware, enterprise software, & IT services Industry Information Technology and Services Type Public Company Founded 1939 Employees 10,001+ Categories Information Technology...
- ...engineering environments. Strong leadership, communication, and collaboration skills are essential, as is the ability to influence senior executives and drive alignment across large, matrixed organizations. The role demands a leader with a customer-first mindset, a passion for...
$70k - $80k
Job Description Job Description Description: Job Summary MAP Retirement is seeking a dynamic and results-oriented Regional Vice President of Sales for our Alabama, Georgia, and Mississippi region to join our growing team. The Regional Vice President will play...Local areaMAP RETIREMENT USA LLC
Vancouver, WA3 days ago$100k - $120k
...Exempt REPORTS TO: President & Chief Executive Officer and Chief Clinical Officer... ...for advancing organizational excellence, regulatory compliance, patient safety, accreditation... ...executive leadership and the Board of Directors. Risk Management & Patient Safety...Full timeTemporary workPart timeLocal areaLifeline Connections
Vancouver, WA21 days ago- ...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...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
- board member Vancouver, WA
- executive support Vancouver, WA
- financial executive Vancouver, WA
- supply chain executive Vancouver, WA
- managing director Vancouver, WA
- information technology executive Vancouver, WA
- restaurant managing partner Vancouver, WA
- hospital ceo Vancouver, WA
- talent acquisition executive Vancouver, WA
- chief executive officer Vancouver, WA