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
$226.5k - $317.1k
About the RoleThe Senior Director Regulatory Affairs Strategy will play a key role in guiding assigned projects throughout development and lifecycle... ...to drive regulatory success.Oversee the development and execution of cutting-edge early-development through post-approval...SuggestedWork at officeLocal areaRemote work$85.56 - $152.95 per hour
...exceptional leadership opportunity. The Role The Executive Director, Imaging Services, serves as the division's key administrative... ...This role requires sound judgment in complex political, regulatory, and economic environments while maintaining alignment with...SuggestedMinimum wageFull timeWork at officeLocal areaShift workProvidence
Santa Ana, CA4 days ago- ...include providing strategic regulatory leadership across the product... ...and business continuity.The Director will be responsible for the Consoles... ...Alcon’s Quality & Regulatory Affairs function, ensuring products... ...for developing and executing regulatory strategies to obtain...SuggestedTemporary workLocal areaRelocationFlexible hours
Alcon MX
Lake Forest, CA3 days ago - ...Sr. Manager / Director, Regulatory Affairs Relocation Required to Southern CA Role Overview We are seeking an experienced regulatory affairs leader... .... Key Responsibilities Lead Regulatory Strategy & Execution Define and deliver comprehensive global regulatory strategies...SuggestedRelocation
Bridgeway Partners
Irvine, CA1 day ago - ...A global pharmaceutical company is seeking a Director of Regulatory Affairs to develop and implement global regulatory strategies for product approval. This role requires at least 7 years of regulatory experience, strong project management skills, and the ability to interface...Suggested
Allergan
Irvine, CA2 days ago $174k - $246k
...supporting the needs and interests of the patients we serve. The Director, Regulatory Counsel reports to the Vice President, Regulatory Counsel... ...Counsel will closely partner with Marketing, Clinical Affairs, Regulatory Affairs, Compliance and other functional groups...Full timeEdwards Lifesciences Belgium
Irvine, CA2 hours ago- ..., Facebook, Instagram, X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy... ...meaningful regulatory assessments and recommendations to executive management. Informs AST and cross‑functional management of...Temporary workWorldwide
PowerToFly
Irvine, CA4 days ago $150k - $160k
...holistic and tailored approach to insurance and risk management.The mission of the Placement Executive is to be an integral part of the team and partner with Advisors, Directors and others in the firm to deliver a high level of service to our clients. This individual...Full timeContract workWork at office- ...are hopeful you will join us as a Chief Executive Officer and help shape the future of... ...Reporting to the CalOptima Health Board of Directors (10 members), the Chief Executive... ...and objectives, ensuring compliance with regulatory requirements and company policies. ~...Contract workTemporary workWork experience placementWork at officeLocal areaRemote workFlexible hoursWeekend workAfternoon shift2 days per week
University of California
Orange, CA1 day ago $95k - $135k
...highly dynamic role balances oversight of the Company's trade compliance program with day-to-day import/export operations to minimize regulatory risk while supporting business objectives and customer requirements.The Trade Compliance Manager will work collaboratively across...Work at officeWorldwide$210k - $230k
...Chief Operating Officer (COO) to serve as a key member of the Executive Leadership Team. Reporting directly to the Chief Executive Officer... ...operate efficiently, meet performance objectives, comply with regulatory and contractual requirements, and advance organizational...Illumination Health + Home
Santa Ana, CA2 days ago- A leading construction firm is seeking a Director, Legal, to serve as the sole in-house legal advisor, manage legal affairs, and ensure compliance within a global environment. The ideal candidate has over 10 years of corporate legal experience, preferably in-house. Responsibilities...Remote work
- ...Executive Director of Strategic Communications About the Company Prestigious university providing science & liberal arts programs Industry Higher Education Type Educational Institution Founded 1913 Employees 501-1000 Categories Education...
$122.36k - $186.64k
...experienced aerospace Senior Manager, FAA Regulatory Compliance Engineer to lead the critical... ...-functional collaborators, and drive execution of the plans.Coordinate with stakeholders... ...capability within the Spaceline Regulatory Affairs team.Required Skills and...Permanent employmentFull timeWork at office- ...Dialysis Services team. Position Overview : As the Executive Director of Dialysis Services , you will oversee the administration... ...efficiency of our dialysis services, ensuring compliance with regulatory standards and best practices in patient care. Key Responsibilities...Relocation package
University Health
Santa Ana, CA2 days ago $150k - $300k
...Growth is our biggest opportunity. You'll work closely with our Director of Sales and commercial team to: Win more business... ...this job? How do we win the next one? Which customers need executive attention? Where should we invest? How do we grow...Contract workWeekend workAfternoon shiftEarly shiftPen Manufacturing
Orange, CA8 hours ago$175k - $190k
...Executive DirectorClearwater at North Tustin is a luxury senior living community in Santa... ...people first and service alwaysThe Executive Director oversees and directs the day-to-day... ...staffing, and compliance to meet financial and regulatory goals.Foster a culture of continuous...Local areaClearwater Living
Santa Ana, CA3 days ago$130k - $150k
Executive Director RCFE Salary Range: $130,000 - $150,000 Oakmont of Orange is a premier senior living community located in Orange, California... ...spread of the COVID-19 or other communicable diseases, per regulatory guidelines. With communities across California, Nevada,...RelocationFlexible hoursOakmont Senior Living
Orange, CA8 hours ago- Overview We are seeking an experienced Survey Crew Chief for our land survey department. You must have experience leading a crew in all types of surveys, including ALTA, Boundary, Topographic and Construction Staking.You must also possess a valid California Driver's License...Work at officeNight shift
TecHOUNDS
Orange, CA3 days ago - ...Job Description Job Description Now Hiring: Executive Director/Administrator - Assisted Living Facility Position Overview:... ...standards of care, fostering a positive community, and ensuring regulatory compliance. Responsibilities: Lead, mentor, and...Local areaImmediate start
Epic Healthcare
Santa Ana, CAa month ago $285k - $360k
...blood disorders. Joining our executive team as Chief Executive Officer... ...the President, Medical Director, and Chief Financial Officer)... ...Operations Management - Ensure full regulatory compliance of all clinic... ...operations organization-wide.Legal Affairs & Contract Management - Serve...Contract workLocal areaFlexible hoursCIBD
Orange, CA9 days ago$120k
...A nonprofit organization supporting families affected by diabetes seeks an Executive Director to lead fundraising initiatives and community outreach. This hybrid role requires strong financial management, excellent communication skills, and a commitment to the mission...Riverwalker Talent
Orange, CA2 days ago$250k - $300k
...manufacturer. The Opportunity We are looking for a Senior Executive - Manufacturing Operations to join the leadership team and... ...optimization Ensure compliance with industry quality standards and regulatory requirements Strategic Growth Develop and execute...Local areaWorldwideRelocation packageKeller Executive Search
Santa Ana, CA9 days ago- ...OPPORTUNITYReporting to the SVP BSA & OFAC Risk and Strategy Director, the VP, BSA & OFAC Data Analytics position is responsible for... ...systems, risk models, monitoring scenarios, risk assessments, and regulatory reporting are supported by accurate data, appropriate...Full timeWork at officeLocal areaImmediate startFlexible hours
- ...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
- ...including walkthroughs, testing support, and evidence production.Automation, AI, Data & Process OptimizationContribute to Finance execution of automation, AI, and data initiatives across accounting operations, close, and reporting processes.Drive adoption of process and...Full timeLocal areaImmediate startFlexible hours
$227.95k - $341.93k
...integrity throughout the organization. This role drives outcomes in regulatory adherence, HIPAA privacy, compliance training, investigations,... ...growth objectives.Provide Strategic Regulatory Guidance to Executive Leadership. Monitor, interpret, and communicate emerging and...Full time- ...Must have multi hospital facility management experience, and a Master's degree is a must. Reports directly to the Chief Executive Officer (CEO) and Chairman and works closely with the Chief Nursing Officer (CNO) to ensure compliance with healthcare regulations...
Suncap Technology
Santa Ana, CA8 hours ago - ...Chief Executive Officer (CEO) About the Company Esteemed provider of publicly funded health coverage programs for low-income families... .... This role involves close collaboration with the Board of Directors, executive leadership team, community partners, providers,...
- ...families, and public education. The successful candidate will be responsible for providing strategic leadership and vision, setting and executing a clear direction that aligns with the mission of the organization. This role involves deepening member engagement, expanding...Local areaRemote work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
- chief Santa Ana, CA
- technology executive Santa Ana, CA
- chief executive officer Santa Ana, CA
- chief of psychiatry Santa Ana, CA
- information technology executive Santa Ana, CA
- chief executive Santa Ana, CA
- store executive Santa Ana, CA
- healthcare executive Santa Ana, CA
- board member Santa Ana, CA
- supply chain executive Santa Ana, CA