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$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- ...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...Suggested
$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...SuggestedFull timeWork at officeLocal areaFlexible hours$148.7k - $297.3k
...California - AlamedaJob Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted Date: 202... ...for diversity, working mothers, female executives, and scientists.The Opportunity This Associate Director Regulatory Affairs will work on-site out of our Alameda, CA...SuggestedWorldwide$268.5k - $380.5k
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UCSF School of Medicine and UCSF Benioff Children’s Hospitals Division of Medical Genetics, Department of Pediatrics Clinical X, HS Clinical, In ResidenceThe Division of Medical Genetics in the Department of Pediatrics at the University of California, San Francisco (UCSF...- ...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
- ...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...
$200k - $225k
...care to the communities we serve. The Role ~ 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 steady, strategic presence who holds the...Full timeWork at officeRelocationFlexible hoursDesigning Justice + Designing Spaces
Oakland, CA2 days ago$172k - $344k
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Oakland, CA11 days ago - ...systems remain compliant, efficient, and aligned with quality and regulatory requirements while supporting continuous improvement efforts... ...assessments, testing, implementation planning, and validation execution. Perform or coordinate User Acceptance Testing (UAT),...Full timeTemporary workLocal area
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