Regulatory Affairs Manager - Gene Therapy (Remote)
Neurogene Inc.
- Remote job
Neurogene Inc. in New York City or remote is seeking a Manager, Regulatory Affairs to lead regulatory strategies and high‑quality submissions for late‑stage programs. You will collaborate across functions, ensuring alignment with global regulatory expectations and timelines. The role requires deep knowledge of GxP, FDA/ICH guidelines, and strong communication to drive efficient filings and program advancement in a fast‑paced gene therapy environment. #J-18808-Ljbffr Neurogene Inc.
$222k - $303k
...’re looking for a Senior Director, Regulatory Affairs CMC - Gene Therapy to help us expand what’s possible for... ...registration and life cycle management.What You'll Do: In this role, you’ll... ....Where You’ll Work This is a fully remote role. It can be performed effectively...Remote workFull timeLocal areaFlexible hours$268.2k - $402.2k
...Executive Director, Regulatory Strategy, Cell & Gene TherapyApplylocations... ...This position will manage a group of global/regional... ...global Regulatory Affairs strategies and... ...1. **Hybrid**: work remotely up to two days per week... ...of investigational therapies across a range of modalities...Remote workSummer workLocal areaFlexible hours2 days per week- ...pioneering personalized CAR T-cell therapies have changed the paradigm.... ...based/hybrid position. The Manager, Regulatory Affairs CMC is located in El... ...approach with two days of remote working and three days working... ...expectations for gene-modified cell therapies and...Remote workFull timeContract workFor contractorsWork at officeLocal areaRelocationFlexible hours
$143.23k - $185.35k
...personalized CAR T-cell therapies have changed the... ...with two days of remote working and three... ...global CMC regulatory strategies for both... ...development and lifecycle management of the T-cell... ...Significant Regulatory Affairs CMC experience in... ...ATMPs/cell and gene therapy products.Strong...Remote workFull timeFor contractorsWork at officeLocal areaRelocationFlexible hours$140k - $160k
...Manager, Regulatory Affairs Remote Iovance Biotherapeutics aims to be the global leader in innovating,... ...tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering... ...in cell therapy, including gene-edited cell therapy, which may be a...Remote workWork at office- ...address the limitations of conventional gene therapy in central nervous system disorders.... ...Overview Work Location: New York City, NY Or Remote. Reports To the Senior Director, Regulatory Affairs Individual Contributor Role The Manager, Regulatory Affairs is responsible for...Remote workContract workShift work
- ...To support clinical regulatory strategy for gene therapy programs, the full-time remote Manager, Regulatory Affairs will manage day-to-day regulatory activities, including preparation and coordination of US and EU submissions and interactions with global health authorities...Remote workFull time
$195.9k - $244.9k
...health, rare diseases, cell & gene therapies and CNS. With several... ...reports to Executive Director, Regulatory Affairs and is part of the... ...Regulatory Lead, if applicable, manage regional (United States and... ...Requirements: Primarily remote role with periodic on-site...Remote workWork at officeLocal areaFlexible hours- Overview Manager, Regulatory Affairs US Remote Emmes Group: Building a better future for us all. Emmes Group is transforming the future... ...has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology,...Remote workCasual workLocal areaWork from homeFlexible hours
$218.06k - $327.09k
...Title: Senior Director, Oncology Cell and Gene Therapy Regulatory AffairsLocation: South San Francisco -CA,... ...against aspirations and update senior management on project risks/mitigation activities. Represent Regulatory Affairs on Global Product Teams (GPTs) providing...Hourly payFull timeTemporary workWorldwideFlexible hours3 days per week$250k - $300k
Menlo Park, CARegulatory Affairs - Regulatory Affairs /Regular, Full-Time Employee... ...next-generation cell therapies with the goal of providing... ...regulatory operations and lifecycle management, while also maintaining... ...as permitted by law. For remote-based positions, this range...Remote workFull timeLocal areaImmediate start- ...Position: Director, Regulatory Writing Location: Remote Job Id: 381 # of... ...Head/SVP, Regulatory Affairs Location: South... ...regenerative and cellular therapies for patients living... ..., clinical), risk management and benefit‑risk... ..., or cell and gene therapies. Experience...Remote work
$210k - $260k
...successfully treated with cell therapies. However, these... .... This role can be remote with regular travel... .... The Director of Regulatory Affairs/Global Regulatory Lead... ...BLA/MAA) and lifecycle management. You will serve as... ...intelligence in the cell and gene therapy field....Remote workTemporary workLocal area$207k - $253k
The Director of Regulatory Affairs, Chemistry Manufacturing Controls... ...the Company’s cell therapy products and... ...readiness, and lifecycle management. This role establishes... ...success.This is a Hybrid or Remote role that requires... ...expectations for cell and gene therapies, biologics,...Remote workWork at officeRelocationWeekend work$195.9k - $244.9k
US-Remote Full time R01517 Sumitomo Pharma Co., Ltd., is a... ...health, rare diseases, cell & gene therapies and CNS. With several... ...reports to Executive Director, Regulatory Affairs and is part of the... ...Regulatory Lead, if applicable, manage regional (United States and...Remote workFull timeWork at officeLocal areaFlexible hours$210.86k - $242.79k
Director, Patient Services Strategy, US Cell & Gene Therapy Office Location: Gaithersburg, MD (3 days minimum per week) Remote is not available for this role. The Director,... ..., and support program operations. Experience managing agencies, consultants, technology vendors, or...Remote workHourly payTemporary workWork at office3 days per week$195.9k - $244.9k
...health, rare diseases, cell & gene therapies and CNS. With several... ...reports to Executive Director, Regulatory Affairs and is part of the... ...Regulatory Lead, if applicable, manage regional (United States and... ...Travel Requirements: Primarily remote role with periodic on-site...Remote workWork at officeLocal areaWorldwideFlexible hours- Vertex Pharmaceuticals LLC seeks a Regulatory CMC Manager to drive international CMC submissions and regulatory strategies for cell and gene therapy programs. You will collaborate with cross-functional teams to ensure regulatory requirements are integrated throughout the...
- ...Somerset, NJ, is seeking a Director of Regulatory CMC to lead global regulatory strategies... ...You will guide cross‑functional teams, manage clinical and commercial lifecycle... ...pharma, including Regulatory CMC and cell/gene therapy experience. #J-18808-Ljbffr BioSpace
$212k - $318k
...Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and... ...technologies for insulin management have helped people with T1D... ...International P&R, Corporate Affairs, US Managed Markets,... ...designated as: 1. Hybrid: work remotely up to two days per week; or...Remote workFull timeSummer workFlexible hours2 days per week- ...Associate Director, Cmc Regulatory Affairs Headquartered in... ...drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide... ...our onsite, hybrid and remote work environments a place... ...Work independently to manage projects and deliver...Remote work
$75 - $85 per hour
...focused on developing cell therapies for patients suffering from... ...an experienced and driven Manager of Regulatory Affairs to join our regulatory team... ...Regulatory Affairs Location: Remote (West Coast hours preferred... .... Experience with cell or gene therapy regulatory affairs....Remote workHourly payContract work$150k - $165k
...of groundbreaking therapies. Our mission is to... ...The Senior Program Manager, Plasmid DNA is... ...Qualification (PPQ), regulatory readiness, and... ...Quality, Regulatory Affairs, Supply Chain, Technical... ...and will be fully remote.In this role, you... ...use in cell and gene therapy, gene...Remote workFull timeWork from homeFlexible hoursNight shift- ...developing transformative gene-based medicines for... ...'s first CRISPR-based therapy, approved for eligible... ...to the Head of Regulatory Affairs, you will work closely... ...required. Ability to manage multiple priorities within... ...workplace that balances remote work flexibility with...Remote workContract work
$160.8k - $201k
...launched our fourth therapy and the first ever gene therapy to treat Duchenne... ...Director of Regulatory Labeling and Disclosures is a US remote based position. You will... ...on Health Authority-managed databases worldwide (... ...the Global Regulatory Affairs team, cross functional...Remote workWork at officeLocal areaImmediate startWorldwide- AstraZeneca in Los Angeles is seeking a Manager of Regulatory & Technical Writing to lead authoring and lifecycle management of regulatory documentation for cell and gene therapy programs, with an immediate focus on BLA submissions and global filings. You will lead planning...Immediate start
$177k - $278.08k
...and delivers transformative therapies to patients. By focusing R&... ....The Director Global Regulatory Affairs, Neuroscience is responsible... ...project team colleagues, line management, and key stakeholders are apprised... ...Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA...Remote workMinimum wageLocal areaWorldwide$177k - $278.08k
...and delivers transformative therapies to patients. By focusing R&D... ...and leads the execution of regulatory CMC investigational, registration... ...team colleagues, line management, and key stakeholders are apprised... ...Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA...Remote workMinimum wageLocal areaWorldwide- ...personalized CAR T-cell therapies have changed the paradigm... ...with two days of remote working and three days working... ...):Develop and implement regulatory product strategiesRepresent... ...authoritiesTrain, manage, and mentor other regulatory affairs personnelWork externally...Remote workFull timeFor contractorsWork at officeLocal areaRelocationFlexible hours
$246.98k - $299.29k
...latest breakthroughs in cell therapy, this is work that transforms... ...is responsible for overseeing management of multiple development and... ...strategic direction based on global regulatory guidelines and experience.... ...centers. Employees in remote-by-design or lab-based roles...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work
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