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
$207.5k - $281k
...our customers all over the world! We are seeking a Principal Regulatory Compliance Manager to serve as a senior technical authority supporting... .... Lead and significantly contribute to the design and execution of compliance monitoring, testing, and control challenge...SuggestedLocal area3 days per weekIntuit
Oakland, CA1 day ago$115k - $130k
...Job Description Job Description: Director of Regulatory Affairs and Policy SupplyBank.org is seeking a strategic, mission-driven... ...and SupplyBank.org initiatives, working closely with the Executive Director, senior leadership, the Board of Directors'...SuggestedWork at officeLocal areaRemote work3 days per weekSupplyBank.Org
Oakland, CA2 days ago$200k - $250k
...degenerative retinal diseases independent of genetic mutation. Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs will play a critical role in leading and executing global regulatory strategy for our clinical-stage programs. This role is ideal for...SuggestedWork at office3 days per week$200k - $235k
...an accommodation or an alternative application process. Director, Regulatory Affairs - CMC Full Time Professional Berkeley, CA, US 7 days ago... ...Regulatory organization, responsible for developing and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory...SuggestedFull time- ...will be responsible for developing and executing an enterprise-wide communications strategy... ...in strategic communications, public affairs, or related areas. The role requires a proven... ...AI, is a plus. Hiring Manager Title Laboratory Director Functions Marketing...Suggested
Confidential
Berkeley, CA3 days ago - ...Fivetran, Inc. is seeking a Senior Director of Tax, Treasury & Compliance based in Oakland, CA. In this full-time role, you will lead tax compliance, optimize tax positions, and drive strategic planning for the company's global entities. You will collaborate with various...Full time
Fivetran, Inc.
Oakland, CA23 hours ago - ...4. About the Role: The Chief Operating Officer (COO) is the executive leader responsible for Jetty's manufacturing, supply chain, and... ...through disciplined governance, quality systems, and regulatory excellence. Champion operational governance that ensures consistent...Full timeContract workTemporary workRelocation
$235k - $260k
...Septerna – Director of Regulatory Affairs Septerna is a biotechnology company based in South San Francisco, CA, focused on developing life‑changing... ...of Regulatory Affairs to lead regulatory strategy and execution across our discovery and development programs. This...Full timeSepterna
San Francisco, CA1 hour ago$159k
...policies and external/internal regulatory requirements. It partners... ...It also leads organizational execution by building strong internal controls... ..., communications or public affairs related position Electric... ...supervision of a manager or director Ability to analyze complex...Contract workWork experience placementWork at officeFlexible hours2 days per week3 days per weekPG&E Corporation
Emeryville, CA1 day ago- Chief Credit Officer (CCO) About the Company Non-profit organization investing in low income community development Industry Financial Services Type Non Profit Founded 1984 Employees 51-200 Categories ~ Social and Rehabilitation...
Confidential
San Francisco, CA1 day ago $265k - $285k
...Senior Director, Regulatory Affairs We are seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a... ...for assigned programs and is a key strategic advisor to executive leadership on regulatory risks, opportunities, and health...Work at officeRemote workFlexible hoursAnnexon Biosciences
San Francisco, CA1 day ago$387k
...Officer is a key leader at the national level and the accountable executive for leading and transforming KPs consumer and patient... ...and physician partners. Leadership experience working with regulatory agencies and dealing with integrated care delivery systems and...Full timeWork experience placementWork from homeFlexible hoursShift workKaiser Permanente
Oakland, CA23 hours ago- ...A leading biotech company in Alameda, California, is seeking an Assoc Scientific Regulatory Writing Director to lead the development of regulatory documents. This role requires extensive experience in the biotech/pharmaceutical industry and a strong understanding of regulatory...Full time
Exelixis, Inc.
Alameda, CA1 hour ago - ...A leading biotechnology firm based in San Francisco is seeking a Director of Regulatory Affairs to lead strategic regulatory initiatives. The role demands expertise in managing regulatory submissions, compliance with health authority requirements, and excellent project...Full time
Septerna
San Francisco, CA1 hour ago $425k
...Chief Executive Officer La Clínica de La Raza La Clínica de La Raza is seeking a... ...0 visits. Reporting to the Board of Directors, the CEO leads La Clínica by setting strategic... ...a strong understanding of the FQHC regulatory environment, including HRSA compliance,...Nahse
Oakland, CA3 days ago- ...Nationwide – Seeking a President & Chief Executive Officer (The Mutual RRG) This is a... ...organization in partnership with the Board of Directors and executive leadership. The... ...analysis Ensure strong internal controls, regulatory compliance, and fiscal discipline...Remote work
Vituity
Emeryville, CA23 hours ago $240k - $275k
Position Summary The Director, Clinical Regulatory Affairs serves as a senior regulatory leader responsible for shaping and executing the global clinical regulatory strategy across Nektar’s development portfolio. This role oversees end‑to‑end planning and delivery of global...Local area- Director of Regulatory Affairs | Job Description About ZBiotics At ZBiotics, we make genetically engineered probiotics that improve daily life.... ...Role As Director of Regulatory Affairs, you will own and execute ZBiotics’ U.S. and international regulatory and policy...Day shift
$85k - $190k
Overall Function: Reporting to the Director of Knowledge Strategy & Enablement, the Senior Compliance Engineer will coordinate product safety, environmental, regulatory, and market-access compliance activities across new product development, sustaining engineering, manufacturing...Full time$285k - $320k
...clarity, speed, and quality of work. What You'll Do Lead CMC regulatory strategy and execution across development and post‑approval programs, ensuring... ...; advanced degree preferred. Extensive Regulatory Affairs CMC experience within the biotechnology and/or pharmaceutical...Work at officeRemote workFlexible hours$210k - $240k
...and backed by venture investors including Y Combinator and Khosla Ventures, among others. About the Role As Director of Regulatory Affairs , you will own and execute ZBiotics’ U.S. and international regulatory and policy strategy. You will help define the pathways that...Work at officeLocal areaHome officeFlexible hoursDay shift- ...to market globally by leading regulatory strategy across the full product lifecycle. The Director owns the overall regulatory strategy... ...business goals Lead and execute regulatory submissions (FDA 510... ...years of progressive regulatory affairs experience with Class II...Work experience placementWork at office
- ...strategic leader with a proven track record in communications, public affairs, and a deep understanding of how to influence and elevate an... ...advisor, with the ability to work closely with the CEO and executive team to elevate the organization's and the CEO's voice. The role...Local area
Confidential
San Francisco, CA1 day ago $200k - $225k
...bring dignity, well-being and care to the communities we serve. The Role Managing Director · Oakland, CA · Hybrid: 3 days in office · $200,000 – $225,000 · Reports to Executive Director The Managing Director is a pivotal executive leadership role at DJDS — a...Full timeWork at officeRelocationFlexible hoursDesigning Justice+ Designing Spaces - Bay Area
Oakland, CA1 hour ago$50 per hour
...Full-time Under the general direction of the Cyber Security and Network Engineer, with a dotted-line reporting relationship to the Director of Infrastructure & Services, the Network & Systems Administrator w... Show more Full-time About the Job Safety and Compliance...Hourly payFull timePart timeSummer workWork at officeWork from homeNight shiftGlobal Selecta
Oakland, CA4 days ago- ...Operating Officer (COO) serves as a key member of Cardea Health's Executive Leadership Team and is responsible for providing strategic and... ...Finance, ensure operational practices and procedures support regulatory compliance, contractual obligations, organizational policies,...Contract workInterim roleWork at officeLocal areaRemote work
Cardea Health
Oakland, CA1 day ago $215k - $250k
We are looking for a Senior Manager of FP&A to become the dedicated owner of Rondo Energy's financial planning engine at a pivotal moment of growth. Fresh off going live with its first ERP (NetSuite), Rondo is now building out its EPM platform and needs a hands-on finance...Full timeFlexible hours3 days per week- ...Revolution Medicines in Redwood City, CA, is seeking an Associate Director, Commercial Regulatory Affairs to partner with cross-functional teams to ensure promotional and medical communications comply with FDA regulations and internal policies. Hybrid work arrangement...Full timeRemote work
Revolution Medicines
San Francisco, CA1 hour ago - ...Executive Director About the Company Reputable metropolitan planning organization Industry Government Administration Type Government Agency Employees 1-10 About the Role The Company is in search of an Executive Director to lead...
Confidential
Oakland, CA2 days ago $80k - $120k
...to deep time liberation. We are seeking to hire a part time Executive Director for the following position and duties. JOB SUMMARY: Reporting... ...procedures, in conjunction with the Board of Directors and regulatory agencies, eg; IRS, Payroll taxes.. Conducts ongoing assessment...Part timeFor contractorsInternshipLocal areaImmediate startFlexible hoursPeace At Any Pace
Oakland, CA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
- housing executive Emeryville, CA
- regulatory contract Emeryville, CA
- regulatory law Emeryville, CA
- regulatory Emeryville, CA
- compliance Emeryville, CA
- regulatory compliance remote Emeryville, CA
- clinical compliance Emeryville, CA
- vendor compliance Emeryville, CA
- compliance lead Emeryville, CA
- regulatory affairs Emeryville, CA