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 Clinical Officer(CCO) to join our Executive Leadership Team in Phoenix. 10+ Years of... ...and CEO. This role drives care delivery, regulatory compliance, quality outcomes, and... ...with Office of Development and External Affairs to drive new initiatives funding opportunities...SuggestedContract workWork at office
- ...serving as a cross-functional liaison, and working closely with the Director of Growth to drive the expansion of the expert community. The... ...setting direction and is equally adept at hands-on execution, and who can effectively engage with stakeholders across various...Suggested
- ...utility company in Phoenix, AZ as our new Regulatory & Rates Director. This crucial role will support the development and execution of regulatory and rates strategy. This position... ...years of experience in rates, regulatory affairs, or with a public utility such as ACC,...Suggested
Kimco Staffing
Phoenix, AZ3 days ago $172.5k - $222.5k
...responsible for: Circle is looking for a Senior Manager to join the Regulatory Assurance team who will help to create a central global... ...results. What you'll work on: Driving the strategy, framework, and execution of the Regulatory Change Management Program.Identifying and...SuggestedFlexible hours$89.25k - $150.25k
...of Compliance Monitoring to support and execute the firm’s ongoing compliance monitoring... ...activities designed to assess adherence to regulatory requirements, internal policies, and... ...framework.The Manager will report to the Director of Compliance Monitoring and work closely...SuggestedFlexible hours- ...solutions across the West Coast. Our innovation and excellence have made us a trusted name in the industry.We are seeking a strategic and execution-focused President & Chief Operating Officer (COO) to lead the company's day-to-day operations and drive the next phase of growth....For subcontractor
Integra Staffing and Search
Phoenix, AZ1 day ago - ...Category:LegalIn the highly visible role of Executive VP, Chief Legal Officer, we seek a... ...for senior leadership and the Board of Directors. A leader who brings intellectual curiosity... ...level business operations with complex regulatory requirements in a healthcare...Full timeContract workShift work
- ...Vice President, Executive Search & Business Development About the Company Nationally recognized executive search firm Industry Staffing and Recruiting Type Privately Held Founded 1979 Employees 1-10 Categories Consulting & Professional Services...
- ...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...
- ...Medical Care Health Centers Clinics Outpatient About the Role The Company is seeking a Business Operations Director & Chief of Staff to play a pivotal role in the strategic and operational management of the organization. The successful candidate...
Confidential
Phoenix, AZ5 days ago - ...role is focused on amplifying the CEO's and SLT's effectiveness, particularly in the areas of time management, decision-making, and execution. The successful candidate will be a trusted partner, gatekeeper, and execution lead, with a strong background in digital and e-...
Confidential
Phoenix, AZ1 day ago - ...significant revenue trajectory, and the successful candidate will be instrumental in optimizing the time, focus, decision-making, and execution of the Senior Leadership Team. The Chief of Staff will be a trusted partner, gatekeeper, and execution lead, particularly in the...Remote work
Confidential
Phoenix, AZ1 day ago - ...Chief Compliance Officer (CCO) you'll oversee and manage the regulatory compliance framework of Western Alliance Bank and all affiliated... ...programs, partnering with business leaders and senior executives to ensure compliance programs remain robust and functional. You...Full time
- Zanes Law Injury Lawyers in Phoenix seeks a Chief Operating Officer to run day-to-day operations across intake, settlements, finance and people. You will directly lead department heads and negotiate contracts within budget, while owning the operating budget and KPI dashboards...
- .... The IT Compliance Manager is responsible for ensuring Sprouts’ IT systems, policies, and processes adhere to applicable legal, regulatory, and industry standards. This role owns IT compliance frameworks including PCI DSS, NIST CSF, and SOX, regulatory adherence, and...Temporary workWork at officeImmediate startFlexible hours
- Location: Phoenix, AZWork Arrangement: In-office Typical Day in the LifeA typical day as an Assurance Manager serves clients in every industry as an assurance and business advisory professional. Supervises complex audits on a regular basis, delegating duties to Associate...Work at officeLocal areaVisa sponsorship
- Skanska is searching for a dynamic Project Executive. This is a great opportunity to start a career with a company that builds things that matter and values its team. We are proud to share our culture of diversity and inclusion.Our work makes a clear contribution to society...Second jobLocal area
- ...Health believes leadership matters. We look for leaders who share our vision making health care easier, so life can be better. Our executives are at the forefront of the health care transformation, planning the future of Banner Health. Your pay and benefits are important...Full timeShift work
- Project Executive/Construction Manager - Manufacturing CenterPosition OverviewWe are seeking a highly skilled Project Executive/Construction Manager to oversee the construction and management of our new manufacturing center. The ideal candidate will have extensive experience...For contractorsFor subcontractor
- As a Project Executive forGraycorConstruction Company, you will lead a portion of business development and operations oversight primarily... ....Communicate with Design Consultants, General Managers, Director of Operations, and the VP/Manager of Estimating to maintain management...For subcontractorCasual workLocal area
$200k - $300k
Job Description Job Description President / COO PE-Backed Flooring Installation & Distribution Company Phoenix, Arizona (Primary) | Orlando, Florida | Travel Required Base Salary: $200,000–$300,000+ | Bonus + Equity The Opportunity A privately backed...Immediate startRelocationRelocation packageSagePaths
Phoenix, AZ20 days ago- Jobtailor in the United States seeks a senior leader to drive regulatory compliance for the PBM business, guiding implementation across operations, systems, and controls. You will partner with Legal and cross-functional stakeholders to embed compliance, oversee investigations...
- ...Staffing Services, Inc. in Phoenix, AZ is seeking a Regulatory & Rates Director to lead the development and execution of regulatory and rates strategy for our utility... ...field, with 10+ years in rates or regulatory affairs, strong ratemaking knowledge, and advanced analytical...
- ...care easier, so life can be better. Our executives are at the forefront of the health care... ...positions, such as Executive Director, Legal Services, to Associate General Counsel... ...operations. Whether advising on healthcare regulatory matters, physician contracting,...Full timeLocal areaShift work
- ...purchasing initiatives. Ensure compliance with government regulatory agencies and accrediting bodies. Negotiate and control... ...body standards. Work in conjunction with the Medical Director and Medical Executive Committee in the evaluation and development of existing...Work experience placementWork at officeLocal areaHome office
United Surgical Partners International
Phoenix, AZ4 days ago - ...Senior Director, IT Compliance & Governance (Contractor) About the Company Innovative company designing & developing gene therapeutic products Industry Biotechnology Type Public Company Founded 2013 Employees 51-200 Categories Biotechnology...For contractors
- Western Alliance Bank, Member FDIC, is a wholly owned subsidiary of Western Alliance Bancorporation, seeking a Regulatory Reporting Oversight (RRO) Financial Control Program Manager to lead QA testing for regulatory reporting within our control framework. You will oversee...
- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry... ...Regulatory Advertising and Promotion to lead the development and execution of the global regulatory strategy for advertising and promotion...
- Zanes Law Injury Lawyers is seeking a Chief Operating Officer to own day-to-day operations across Intake, Settlements, Finance and People, with real authority and direct accountability. In Phoenix at 3333 E. Camelback Rd, this role partners with the founders as a true...
- ...CorporateShift: DayCategory: Legal Role Overview Executive Vice President, Chief Legal Officer – a... .... Provides counsel to the Board of Directors, senior leadership, and management... ...and keep the senior team updated on regulatory changes. Maintain comprehensive regulatory...Contract work
Banner Health Corporate
Phoenix, AZ5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
- executive assistant to chief executive officer Phoenix, AZ
- financial executive Phoenix, AZ
- executive search company Phoenix, AZ
- managing director of operations Phoenix, AZ
- senior manager executive compensation Phoenix, AZ
- chief dental officer Phoenix, AZ
- information technology executive Phoenix, AZ
- executive program manager Phoenix, AZ
- store executive Phoenix, AZ
- nonprofit board member Phoenix, AZ