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: Gaithersburg, 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$248k - $352.5k
...development and implementation of global regulatory strategies that align with asset and... ...expedited pathways. Represent Regulatory Affairs in multi-disciplinary teams to establish... ...acting with integrity to build trust and execute on team objectives and departmental goals...SuggestedFull timeContract workWork at officeLocal areaFlexible hours- Exelixis, Inc. seeks an Executive Director of Regulatory Affairs to oversee all regulatory activities from pre-IND through BLA/NDA and post-approval. Lead global regulatory strategies across clinical, non-clinical, and CMC disciplines, translating requirements into practical...Suggested
$268.5k - $380k
SUMMARY/JOB PURPOSE The Executive Director, Regulatory Affairs has oversight for all regulatory activities for new development programs, pre-IND through BLA/NDA and post-approval. Responsible for developing and implementing global regulatory strategies encompassing clinical...SuggestedWork at officeLocal areaFlexible hours$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...Suggested3 days per week- ...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 51... ...of progressive regulatory affairs experience with Class II medical...
- ...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... .... Hiring Manager Title Laboratory Director Functions ~ Marketing...
$195k - $277.5k
...development and implementation of global regulatory strategies that align with asset and... ...expedited pathways. Represent Regulatory Affairs in multi-disciplinary teams to establish... ....JOB COMPLEXITY:Capable of managing the execution of multiple tasks. Ensures appropriate prioritization...Full timeWork at officeLocal areaFlexible hours$148.7k - $297.3k
...companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.The Opportunity This Associate Director Regulatory Affairs will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re...WorldwideShift work$268.5k - $380.5k
...sciences, and early development. Shape and execute biologics research and development... ...the Biotherapeutics team, the Executive Director of Biologics Innovation & Strategy plays... ...sciences, translational medicine, CMC, regulatory, and clinical development.Lead scientific...Full timeWork at officeLocal areaFlexible hours- ...coding compliance regulations and requirements managed care contractual terms and requirements, health insurance practices, industry regulatory requirements, business office operations, accounting, and industry standards for healthcare revenue resolution management...Full timeFor contractorsWork at officeShift work
$114k - $228k
...a best place to work for diversity, working mothers, female executives, and scientistsAt Abbott, we believe people with diabetes should... ...their glucose levels with our new sensing technology. This Regulatory Affairs Manager position is an onsite opportunity working out of...Shift work$114k - $228k
...best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.The Opportunity This Regulatory Affairs Manager - APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division....Shift work$165k - $230k
...to ensure alignment with financial reporting risks. *• Review control documentation and collaborate with control owners to ensure execution of processes and documentation are adequate.• Partner with internal audit, external audit, and control owners to coordinate ITGC and...Temporary workWork at officeLocal area$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 placementFlexible hoursShift workKaiser Permanente
Oakland, CA3 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 ...
$270k - $340k
...150M to date. The Role Profluent is seeking an exceptional Executive Director / Vice President, Biology & Translational Pharmacology to lead... ..., delivery, computational biology, bioanalytics, CMC, regulatory, and external CROs to generate rigorous, decision-enabling data...$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, CA4 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
- The University of California - San Francisco is seeking a leader in Health Information Management to oversee all outpatient coding operations. The role requires extensive experience in coding and healthcare operations, with an emphasis on compliance and quality assurance...
- Exelixis, Inc. in Alameda, CA is seeking an Assoc Regulatory Affairs Strategy Director (Oncology) to lead global regulatory strategies, ensure timely submissions, and guide study teams. The role requires senior-level expertise in regulatory affairs and collaboration with...
- Exelixis, a leader in oncology, seeks an Executive Director, Regulatory Affairs to guide global regulatory strategies from early development through post-approval. You will oversee program leaders, ensure timely IND/NDAs/BLAs submissions, and maintain strong FDA relationships...
$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, CA4 days ago$151k
...and risk in all that we do and achieve regulatory outcomes that support the business’ needs... ...Relationship This position reports to the Director, Electric Investigations Job... ...findings and risk to PG&E to senior and executive leaders. Stand up new compliance control...Work experience placementWork at officeRemote workFlexible hoursNight shiftPacific Gas And Electric Company
Oakland, CA4 days ago- ...Summary: Reporting to the head of External Communications, the Executive Director, Public Relations serves as the enterprise leader for... ...and priorities move across the system, and helping the Public Affairs leadership team align communications, reputation, policy, and...
- DescriptionJob Summary: The Executive Director, Federal Government Relations - D.C. Office serves as a senior federal advocate responsible... ...objectives. Working in close partnership with policy leaders, public affairs, and internal stakeholders, this position translates...Work at officeLocal area
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...objectives, health authority guidelines, and regulatory requirements. Develops and/or applies... ...the biostatistics function.Interpret, execute, and recommend modifications to companywide... ...operation, clinical science, regulatory affairs, and drug safety.Project management and...Full timeContract workInterim roleWork at officeLocal areaFlexible hours- ...Mutual RRG. Vituity is supporting the executive search process on behalf of the organization... ...in partnership with the Board of Directors and executive leadership.The Opportunity... ...analysisEnsure strong internal controls, regulatory compliance, and fiscal...Full timeRemote work
$323k
UCSF School of Medicine and UCSF Benioff Children’s Hospitals Division of Pediatric Cardiology, Department of Pediatrics Clinical X, HS Clinical, In ResidenceThe Division of Pediatric Cardiology in the Department of Pediatrics at the University of California, San Francisco...- Kyverna is seeking a senior program leader to drive the enterprise compliance buildout and commercialization-readiness initiatives. This role coordinates cross-functional workstreams, owners, milestones, dependencies, and risk escalation while aligning with corporate objectives...
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