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$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...SuggestedWork at officeLocal areaRemote work3 days per weekSupplyBank.Org
Oakland, CA4 days ago- ...Eko Health is seeking a Director of Regulatory Affairs in Emeryville, CA, to lead global regulatory strategy across the full product lifecycle for... ...requirements into development workflows and guiding executive decisions. The role requires 10+ years in regulatory affairs...Suggested
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...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...Local areaFlexible hoursExelixis
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Confidential
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- ...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...
$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...Full timeContract workWork 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
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$165k - $230k
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...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$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- 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
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