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
- ...Chief Operating Officer/Executive Vice President of Operations (COO/EVP) Job Category : Executive Requisition Number : CHIEF... ...accountability across the network. Lead and develop executive directors and local operational teams. Partner with physicians and...SuggestedFull timeLocal area
Pinnacle Fertility, Inc.
Scottsdale, AZ1 hour ago $85k - $95k
...BASE COMPENSATION $85,000 - $95,000 annually LOCATION Scottsdale, AZ WORKPLACE SETTING Onsite POSITION SUMMARY The Executive Assistant to the President & COO operates as an extension of the executive helping drive prioritization, decision flow, and overall effectiveness...SuggestedLocal areaImmediate startShift work10xhealthsystem
Scottsdale, AZ2 days ago$115k - $145k
What The Role Is The Manager, Regulatory Compliance, will assist in the management of the Clearway Energy Group electric regulatory compliance program and in administering, facilitating, and managing compliance with NERC and other federal electric regulatory requirements...SuggestedH1bWork at officeVisa sponsorshipRelocation package- ...Carolyn Eynon Singers Seeks Volunteer Executive Director for 20th Anniversary Season A Unique Opportunity for Graduate Students and Emerging Arts Leaders This position provides firsthand experience in nonprofit arts leadership and may serve as an internship...SuggestedInternship
Carolyn Eynon Singers
Scottsdale, AZ5 days ago - ...Executive Director Contract to hire role (approximately 3-6 months contract) Hybrid is preferred at one of these locations: Buffalo Grove, Dallas and Scottsdale If they are a rockstar then they will consider remote but they would have to travel into a location...SuggestedContract workRemote work
Samprasoft
Scottsdale, AZ2 days ago - ...and comfortable on the job. We’re looking for a visionary, driven, and self-directed Chief Growth Officer (CGO) to architect and execute Tribal Health’s strategic growth plan. This role is not for passive operators—it’s for a builder who thrives on creating...Full timeContract workImmediate startNight shift
Tribal Health
Scottsdale, AZ2 days ago - The Reinalt-Thomas Corporation is seeking a Chief Information Security Officer (CISO) to oversee enterprise-wide cybersecurity and risk management strategies. As a critical leadership role, the CISO will be responsible for protecting corporate information systems and ensuring...
The Reinalt-Thomas Corporation
Scottsdale, AZ1 day ago - ...A rapidly growing organization in the employee benefits and insurance services industry is seeking a strategic, hands‑on sales executive to lead and scale its revenue organization. This is an opportunity for a proven sales leader to step into a highly visible role where...
Renaissance Personnel Group
Scottsdale, AZ4 days ago - ...relationship. Private Client Group (PCG) — the division dedicated to Ultra-High-Net-Worth clients — leadership is seeking a proven executive to take the helm of the West Region , based in Scottsdale, Arizona . This is a rare, high-visibility role at a pivotal moment....Shift work
Vanguard
Scottsdale, AZ2 days ago - ...The Position CARE is seeking a dynamic, strategic, and relationship-driven Executive Director to lead the organization into its next chapter of growth and impact. This individual will be responsible for driving revenue growth, strengthening community engagement, and advancing...Temporary work
Cancer Awareness through Research & Education (CARE)
Scottsdale, AZ1 day ago - Job Description Job Description Position Summary The Vice President, Real Estate (West Region) is responsible for overseeing the diligence materials and transactional documents for real estate acquisitions and dispositions on behalf of the Walton Legal department...Local areaImmediate start
Walton Global Holdings, LLC
Scottsdale, AZ15 days ago - ...your placements or your personal recruiting business. Whether your ambitions include achieving 7-figure commissions, establishing executive-level client connections, or launching your own vertical under our banner, we offer you the tools to reach your aspirations. Your...Permanent employmentRemote workShift work
MLee Medical Employment
Scottsdale, AZ2 days ago - ...by identifying, developing, and securing new business opportunities within the hospitality, travel, and loyalty industries. This executive will leverage an extensive network of senior decision-makers to build strategic partnerships, open doors, and close high-value enterprise...Contract workWork at officeLocal areaImmediate start
Kids for the Future
Scottsdale, AZ1 day ago - Enterprise Bank & Trust was founded in the spirit of entrepreneurship and community. From the small mom-and-pop coffee shop to the large construction company that employs local people, our goal is to help businesses succeed and our communities thrive. With offices in...Full timeLocal area
Enterprise Bank and Trust
Scottsdale, AZa month ago - Cardone Ventures in Scottsdale, AZ seeks a Home Services Advisor to provide operational advisory and consulting for clients. The role involves preparing metrics reports and optimizing home services businesses, ensuring alignment and accountability for results. The ideal...
Cardone Ventures
Scottsdale, AZ3 days ago - ...the efficiency of current business functions, planning changes and updates to day-to‑day operations and collaborating with other executive staff to set and meet business objectives. Position Responsibilities Provide management to staff and leadership to the organization...Immediate startNight shift
Tribal Health
Scottsdale, AZ4 days ago - ...Executive Vice President Our client is currently seeking an Executive Vice President who will oversee a portfolio of housing communities... ...to mitigate risks. Informed about market conditions, regulatory changes, and industry best practices. Identify and implement...
Blue Castle Agency
Scottsdale, AZ1 day ago $400k
The Phoenix VA Radiology Service is seeking a Section Chief of Imaging Informatics. The Radiology Service at the Phoenix VA Health Care System (PVAHCS) Medical Center in Phoenix, Arizona provides Radiology subspecialty services, inpatient, outpatient, and emergency services...Contract workFreelanceWork at officeLocal areaRelocation package- At Sunflower Bank, N.A., we're experiencing great growth. Since our founding in 1892, we've been committed to serving our communities and supporting the team members who make it all possible. As a full-service financial institution, we offer a full range of relationship...Full time
Sunflower Bank, N.A.
Scottsdale, AZ1 day ago - ...seamless communication. Manage and prioritize incoming requests, ensuring timely responses and follow-ups. Assist in the planning and execution of company events, board meetings, and other important functions. Office management to include support of day-to-day office...Full timeWork at office
MissionRT
Scottsdale, AZ1 day ago - ...technologies, and build scalable platforms powering Brand Ambassadors and customers worldwide. You will partner with an exceptional Executive Leadership Team to influence strategy, drive AI adoption, and develop a world-class technology organization focused #J-18808-...Worldwide
Plexus Worldwide
Scottsdale, AZ4 days ago - A global consulting firm in Scottsdale seeks an experienced Investment Banking Consulting Manager to lead major transformation programs for global investment banks. This role involves client interaction across the trading lifecycle and requires 7+ years in Financial Services...
Accenture
Scottsdale, AZ1 day ago $150k - $175k
...of Human Resources serves as a strategic business partner to executive leadership and leads all aspects of the Human Resources function... ...to support organizational performance. Support the Board of Directors and Compensation Committee through executive compensation planning...Work at officeLocal area3 days per weekThe Joint
Scottsdale, AZ1 day ago- ...Regional Executive Director Cogir Senior Living, based in Scottsdale, Arizona, proudly oversees a network of senior living communities... ...facility-based policies and procedures, exceeding state and regulatory minimum requirements. Conduct comprehensive rounds assessing...Interim roleWork at officeMonday to Friday
Cogir Senior Living
Scottsdale, AZ4 days ago - ...usual, we welcome you to explore the unique opportunities within our firm. Key Responsibilities Strategic Visionary: Create, own, and execute a growth strategy that aligns with Letsscale's vision. This includes setting clear objectives, priorities, and key results. Revenue...
LetsScale
Scottsdale, AZ3 days ago $50 - $55 per hour
...Job Posting: Executive Protection Agent Purpose We are seeking highly skilled and experienced Executive Protection Agents to join our team. As an Executive Protection Agent, you will be responsible for providing top‑tier security and surveillance services to our clients...Hourly payFull timeContract workPart timeImmediate startFlexible hoursShift workNight shiftDay shiftFortified Risk Group
Scottsdale, AZ2 days ago- ...roadmap aligned to business strategy, integrating best practices in lean, digitization, change management, and strategic program execution. Locations: Scottsdale, AZ, San Antonio, TX, Dallas, TX, Cincinnati, OH, Maryville, TN, or near other US StandardAero facilities What...Temporary workWork at officeWorldwideFlexible hours
StandardAero
Scottsdale, AZ1 day ago - ...successful candidate will be responsible for leading the end-to-end execution of M&A transactions, both on the sell-side and buy-side. This... ...the transaction lifecycle, as well as support the Managing Directors in origination efforts and mentor junior bankers. Applicants...
Confidential
Scottsdale, AZ2 days ago - ...About the Role The Company is seeking a Vice President of Partnerships to play a pivotal role in the strategic leadership and execution of the organization's mission. The successful candidate will be responsible for the design and development of processes and...
Confidential
Scottsdale, AZ3 days ago - A leading consulting firm in Scottsdale, Arizona is looking for a Chief Growth Officer (CGO) who will spearhead its growth strategy and drive revenue generation. The ideal candidate will have proven experience in a high-level growth role, a strong network for building ...
LetsScale
Scottsdale, AZ2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
- chief executive officer Scottsdale, AZ
- assisted living executive director Scottsdale, AZ
- nonprofit board member Scottsdale, AZ
- store executive Scottsdale, AZ
- chief of police Scottsdale, AZ
- president & ceo Scottsdale, AZ
- chief diversity officer Scottsdale, AZ
- ceo Scottsdale, AZ
- chief of psychiatry Scottsdale, AZ
- hospital ceo Scottsdale, AZ