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
$285k - $320k
...speed, and quality of work. WHAT YOU'LL DO Lead CMC regulatory strategy and execution across development and post-approval programs, ensuring... ...required; advanced degree preferred * Extensive Regulatory Affairs CMC experience within the biotechnology and/or...SuggestedFull timeWork at officeRemote workFlexible hours- 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...Suggested
Confidential
San Francisco, CA1 day ago - ...GondolaBio, a clinical-stage biopharmaceutical company, seeks an experienced regulatory affairs leader to drive global strategy for early clinical programs addressing genetic diseases. You will own IND/CTA planning and navigate accelerated pathways, partnering with cross...Suggested
GondolaBio
San Francisco, CA3 days ago $193.4k - $241.8k
...of 3 days per week. Position Summary Join a highly visible Regulatory Affairs team where you'll help shape promotional strategy for innovative... ...Significant demonstrated experience developing and executing complex and innovative global regulatory strategies, assessing...SuggestedWork at officeLocal areaRemote workNight shift3 days per weekACADIA Pharmaceuticals
San Francisco, CA1 day ago$244k - $305k
...Revolution Medicines is seeking a seasoned professional for regulatory management in oncology. The ideal candidate will have over 12 years... .../biotech industry and a minimum of 8 years in Regulatory Affairs. Responsibilities include directing regulatory strategy for late...SuggestedREVOLUTION Medicines
San Francisco, CA1 day ago$240k - $275k
...The International Executive Service Corps is hiring a Director of Clinical Regulatory Affairs to shape and execute the global clinical regulatory strategy. The role involves overseeing clinical submissions and ensuring compliance with regulatory requirements. The ideal...International Executive Service Corps
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$230k - $270k
...in the immune system. Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of... ...Regulatory organization, responsible for developing and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory...Corvus Pharmaceutical
San Francisco, CA1 day ago$275k
...candidate will be a core member of the Regulatory team and will serve as the global regulatory... ...of that strategy guiding and executing compliant, high quality, nonclinical and... ...works cross-functionally with regulatory affairs and clinical development organizations to...For contractorsPlanet Pharma
San Francisco, CA1 day ago- 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
$200k - $250k
...rare and large market indications. Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs CMC will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturing, and Controls (CMC)...$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$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- ...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
$221.9k - $390.3k
...Salesforce ecosystem Partner with Product and Engineering on roadmap alignment and investment prioritization Business Leadership & Executive Alignment Responsible for driving the effectiveness of the Slack ELT and amplifying the impact of the CEO/GM Define...100 Salesforce, Inc.
San Francisco, CA1 day ago$200.7k - $234.15k
...of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. The Associate Director, Regulatory Affairs reports to the Executive Director of Regulatory Affairs and performs hands‑on regulatory activities across development stages,...Cytokinetics
San Francisco, CA3 days ago- ...Chief Executive Officer (CEO) and Chief Operating Officer (COO) About the Company Well-regarded independent company in the FMCG & CPG sectors Industry Food & Beverages Type Privately Held About the Role The Company is in search of a dynamic...Worldwide
Confidential
San Francisco, CA2 days ago $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 programs...3 days per weekIntuit
Oakland, CA3 hours 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...
$180k - $300k
...in ambiguous and demanding environments, holds extremely high standards and has the ability to move from board-level strategy to execution detail without compromise. For the right person who wants to build, this is the perfect accelerant to owning your own P&L, ideally...Full timeWork experience placementWork at officeLocal area$120k - $160k
...company scales. What You'll Do Work directly with founders across strategic priorities, operational initiatives, and day-to-day execution Translate high-level strategy into actionable roadmaps and drive cross-functional initiatives to completion Coordinate across GTM...Full timeWork at officeVisa sponsorshipWork visaShift work$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
Brisbane, CA1 day 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
San Francisco, CA2 days ago - ...Regulatory Manager We are seeking an experienced and highly motivated Regulatory Manager to join our Regulatory Affairs team. In this role, you will be responsible for developing and executing regulatory strategies to ensure compliance and successful product approvals...Work at office
Cedent Life Talent
San Francisco, CA20 hours ago $187.6k - $281.4k
Why Harvey At Harvey, we're transforming how legal and professional services operate. By combining frontier agentic AI, an enterprise-grade platform, and deep domain expertise, we're reshaping how critical knowledge work gets done for decades to come. This is a...Harvey
San Francisco, CA1 day ago- ...experienced and highly motivated Compliance Director to lead our Affordable Housing... ...inspections, and reporting requirements. Monitor regulatory changes and implement operational... ..., Property Managers, Leasing Teams, and Executive Leadership on compliance matters. Review...Work at officeLocal area
Bell Properties Inc
San Francisco, CA3 hours ago - ...Ray Therapeutics, Inc. is seeking a Director of Regulatory Affairs to lead global regulatory strategy for clinical programs. Reporting to the Chief Regulatory Officer, you will oversee INDs and early-to-mid stage development, prep for NDA/BLA discussions, and guide cross...
Ray Therapeutics, Inc.
Berkeley, CA1 day ago $133.2k - $172.37k
...three days onsite. Responsibilities Prepare regulatory submissions requiring interaction with departments outside of Regulatory Affairs for investigational and commercial... ...guidance of the immediate manager, plan and execute own self‑development and acquire required...Local areaImmediate startRemote workRelocationFlexible hoursKite Pharma
San Francisco, CA3 hours ago$245k - $285k
...candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory... ...processes, procedures, and tools to facilitate effective execution by the regulatory function across the organization. This...Contract workSentibio
South San Francisco, CA3 days ago$115k - $130k
...Job Description: Director of Regulatory Affairs and Policy SupplyBank.org is seeking a strategic, mission-driven Director of Regulatory Affairs... ...and SupplyBank.org initiatives, working closely with the Executive Director, senior leadership, the Board of Directors’ Oakport...Work at officeLocal areaRemote work3 days per weekSupplyBank.org
Oakland, CA3 hours 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 president San Francisco, CA
- chief development officer cdo San Francisco, CA
- chief executive officer San Francisco, CA
- assisted living executive director San Francisco, CA
- nonprofit board member San Francisco, CA
- store executive San Francisco, CA
- chief of police San Francisco, CA
- president & ceo San Francisco, CA
- chief diversity officer San Francisco, CA
- ceo San Francisco, CA