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
$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: NYC, NYGaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory direction for first-in-class cell therapies...SuggestedHourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week- (Executive) Director, Regulatory Affairs, CMC Philadelphia or San Francisco Office About us Our purpose at Dispatch is to help create a world where all cancer patients can be cured. We’re humbled by the opportunity to work together as a team on some of the most pressing...SuggestedContract workWork at officeFlexible hours
$265k - $285k
...staffingfuture.comResponsibilities include: Provides regulatory leadership in support of the development... ..., Clinical Operations, Medical Affairs, CMC, and Quality to develop, coordinate... ...excellence and successful execution of corporate objectives.Other duties as...Suggested- ...internationally to rapidly advance our pipeline. Position Summary Reporting to the Vice President, Regulatory Affairs, the Director/Senior Director/Executive Director, Regulatory Affairs leads regulatory strategy and submission execution for one or more oncology...Suggested
Bridge Bio Oncology Therapeutics
South San Francisco, CA2 days ago - ...conditions and to provide therapy. We are looking for a Director of Regulatory Affairs and Quality Assurance to help build a business around this... ...This role will interact closely with R&D, Clinical, and the executive team. Your work will improve the lives of numerous users...SuggestedNight shift
Eight Sleep
San Francisco, CA4 days 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 strategy...Day shift
ZBiotics
San Francisco, CA2 days 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, CA4 days ago- ...implement global clinical & nonclinical regulatory strategies for immunology and inflammation... ...operational plans. Represent Regulatory Affairs on assigned cross-functional development... ...and interpreting feedback. Develop and execute long-term regulatory strategy, including...For contractors
- Senior Director Regulatory Affairs Strategy My client is seeking a highly experienced and strategic Director or Senior Director of Regulatory Affairs to lead global regulatory strategies supporting product development and commercialization across key international markets...
$232k - $274k
Job Summary: Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory... .... This role will be responsible for developing and executing the global regulatory strategy in collaboration with key...For contractorsWorldwide- Position Title: Director, Regulatory Affairs (Strategy, Immunology and Inflammation) Nurix Therapeutics is a clinical stage biopharmaceutical... ...as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions...For contractorsWork at office
- ...standards, establishing accountability, and driving a culture of compliance that extends to enterprise-wide privacy, cybersecurity, and regulatory change. Applicants must have at least 12 years' of progressive investment management compliance experience, with a strong...
$210k - $260k
...our Seattle, WA or South San Francisco, CA offices. The Director of Regulatory Affairs/Global Regulatory Lead (GRL) will be focusing on the... ...in oncology. As the GRL, you will define, develop, and execute the global regulatory strategy for assigned CAR-T programs...Temporary workLocal areaLyell Immunopharma
San Francisco, CA4 days ago- ...conditions and to provide therapy. We are looking for a Director of Regulatory Affairs and Quality Assurance to help build a business around this... ...role will interact closely with R&D, Clinical, and the executive team. Your work will improve the lives of numerous users...Full timeImmediate startWorldwideFlexible hoursNight shift
Eight Sleep
San Francisco, CA12 days 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 Services ...
$103k - $138k
...supporting strategic risk planning for Pattern’s projects during execution, with a primary focus on wind, transmission, and solar energy... ...with internal project teams, consultants, contractors, regulatory authorities, and local interest groups to ensure Pattern’s projects...Full timeTemporary workFor contractorsWork experience placementLocal area$211k - $264k
...with cancers harboring mutations in the RAS signaling pathway. The Opportunity The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of global regulatory NDA/MAA filings for late-stage oncology programs at RevMed....Full timeWork experience placementLocal area$190k - $210k
...career, and for what’s beyond.About the Role >>>Associate Director, Global Regulatory Affairs, ComplianceAs the Global Associate Director, Regulatory... .... You will partner cross-functionally to develop and execute regulatory strategies towards compliance that support the...Work at officeFlexible hours2 days per week$263.88k - $307.86k
...pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Reporting to the Executive Director, Regulatory Affairs, the Senior Director, Regulatory Affairs, REMS Program is responsible for leading regulatory strategy and execution...For contractors$337.5k - $393.8k
...seeking a strategic leader for the role of Executive Director, U.S. Healthcare Compliance. In... ...as we scale our commercial and medical affairs operations and patient support programs... ...and state laws and regulations and self-regulatory codes and guidelines applicable to the...$218.06k - $327.09k
Job DescriptionThe Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy... ...CMC, Labeling and members of the submission and execution team. Participate in coaching and performance feedback...Hourly payFull timeTemporary workWorldwideFlexible hours3 days per week$127k - $165k
...careerAbout This Role:Responsibilities include:Developing and executing regulatory strategies for new and modified medical devices in line with... ...required.> 8-10 years minimum of US and/or EU regulatory affairs experience with a Bachelor’s degree; 6 years minimum of US and...Full timeRemote work- ...different stakeholder groups without dropping the ballStrong written and verbal communication skills; you can translate complex regulatory requirements into clear, actionable guidance for cross-functional stakeholdersA natural collaborator who builds trusted relationships...Contract workFor contractorsFor subcontractorWork at officeLocal area
- ...operations, and data teams to build operationally efficient and effective programsWhat We’re Searching For:3+ years of experience in regulatory compliance, business banking, or commercial cardFamiliarity with vendor management, SOC1, SOC2, risk management and GRC processes...Flexible hours
$216.3k - $400.9k
...world. Progress starts with you.Job DescriptionVisa's Global Executive Talent Acquisition function is seeking an exceptional executive... ...across regional and global executive labor markets, cross-border regulatory considerations, cultural nuances, and executive compensation...Full timeWork experience placementWork at officeLocal areaWorldwide$275k - $280k
...Position Description: Calico is seeking a Regulatory Director that will be responsible for, in... ...Responsibilities: Accountable to develop and execute the world-wide regulatory strategy for... ...strategies Represent Regulatory Affairs on development teams and support development...Full time$153k - $245k
...technologiesEstablished connections in the FedRAMP industry and with various government agenciesFamiliarity with other international regulatory complianceAt Figma, one of our values is Grow as you go. We believe in hiring smart, curious people who are excited to learn and...Minimum wageFull timeLocal areaRemote workFlexible hours- ...Job Overview: 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. You...Contract workWork at office
- Eight Sleep is seeking a Director of Regulatory Affairs and Quality Assurance to lead risk management and oversee the quality management system.... ...agencies and collaborate closely with R&D, Clinical, and the executive team. The role is rooted in San Francisco. You’ll drive...
- ...and NVIDIA. Learn more about our vision, team, and backers at About the Role We’re looking for a Policy & Regulatory Affairs Manager to help shape and execute our policy and regulatory strategy at a critical moment of growth. As demand accelerates and regulatory...Work from homeFlexible hours2 days per week
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
- managing director of operations San Francisco, CA
- executive underwriter San Francisco, CA
- associate chief medical officer San Francisco, CA
- nonprofit board member San Francisco, CA
- survey crew chief San Francisco, CA
- technology executive San Francisco, CA
- process executive San Francisco, CA
- executive consultant San Francisco, CA
- executive functioning San Francisco, CA
- managing director financial services San Francisco, CA