Remote Director, Global Regulatory Strategy, Gene Therapy
Asklepios Biopharmaceutical Inc
- Remote job
AskBio Inc., a Bayer subsidiary, seeks a senior Regulatory Affairs leader to drive global regulatory strategies for gene therapy programs. The role focuses on preclinical and clinical development, coordinating with cross-functional teams and external partners to align with health authority expectations in the U.S., EU, and ROW. The position involves leading regulatory submissions, agency interactions, and development-stage activities, including CTAs, INDs, and designations, with an emphasis on #J-18808-Ljbffr Asklepios Biopharmaceutical Inc
$177k - $278.08k
...innovation and delivers transformative therapies to patients. By focusing R&D... ...patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for... ...position is currently classified as "remote" in accordance with Takeda's...Remote workMinimum wageTemporary workLocal areaWorldwide$212k - $318k
...Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease... ...faster than ever before.The Director, T1D will serve as a T1D... ...(CGT) portfolio in the Global Value and Access Strategy (GVAS) team.The individual... ...designated as: 1. Hybrid: work remotely up to two days per week;...Remote workFull timeSummer workFlexible hours2 days per week$268.2k - $402.2k
## Executive Director, Regulatory Strategy, Cell & Gene TherapyApplylocations: Boston, MA: Washington... ...of innovative global regulatory strategies for... ...as: 1. **Hybrid**: work remotely up to two days per week;... ...pipeline of investigational therapies across a range of modalities...Remote workSummer workLocal areaFlexible hours2 days per week- Eli Lilly and Company seeks a Director/Senior Director, Regulatory CMC to lead regulatory CMC strategies for our gene therapy portfolio, guiding from development through commercialization... ...the main liaison with health authorities globally. This role requires 5+ years in...Suggested
- Jobtailor in Boston is seeking a Senior Regulatory CMC Leader to develop and implement global regulatory CMC strategies for gene therapy programs, lead submission activities, and act as the primary liaison with health authorities such as the FDA and EMA. You will guide...Suggested
$177k - $278.08k
...and delivers transformative therapies to patients. By focusing R... ...to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is... ...innovative global regulatory strategies and providing strategic... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-...Remote workMinimum wageTemporary workLocal areaWorldwide$177k - $278.08k
...and delivers transformative therapies to patients. By focusing R&D... ...worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry... ...develops the regulatory CMC strategy and leads the execution of... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA...Remote workMinimum wageTemporary workLocal areaWorldwide$238k - $374k
...and delivers transformative therapies to patients. By focusing R... ...worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug... ...and robust regulatory strategies for medical devices and drug... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-...Remote workMinimum wageTemporary workWork at officeLocal areaWorldwide$169.5k - $248.6k
...invite you to join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the accountable... ...& execution of global regulatory strategies— from portfolio entry through end of life... ..., IN and relocation is provided, remote is not available for this role.Additional...Remote workLocal areaRelocationFlexible hours$258.68k - $313.46k
...to the latest breakthroughs in cell therapy, this is work that transforms the lives... ...careers.bms.com/working-with-us.Sr Director, Global Regulatory Strategy, NeuroscienceWill be a key member of... ...capability centers. Employees in remote-by-design or lab-based roles may be...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA- Remote Be a part of a global team that is inspired to make... ...and deliver life-changing therapies to people living with... ...Position Summary: The Director, Regulatory Affairs Strategy is responsible for developing...Remote workTemporary workLocal areaWeekend work- Sentibio in South San Francisco seeks a regulatory affairs leader to drive CMC strategies for a complex cell therapy program. You will shape global regulatory CMC plans, coordinate type B... ...extensive experience in biologics and gene/cell therapy. Some travel (approx. 20%)...
- AstraZeneca is seeking a Director of Regulatory Affairs Strategy for cell therapy in the United States. The role focuses on shaping global regulatory strategy for CGT programs spanning oncology and immune-mediated diseases, translating breakthrough science into timely approvals...
- Travere Therapeutics is seeking a Director, Regulatory Affairs Strategy to develop and execute global regulatory strategies for Phase 2 and Phase 3 programs. You will work closely with teams to ensure compliance and strategic alignment with regulatory bodies. The ideal...Remote job
- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute global regulatory strategies for Phase 2 and Phase 3 clinical development programs. This role involves close collaboration with Clinical Development and other teams to drive...Remote job
- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy based in Washington, DC, to develop and execute global regulatory strategies for late-stage clinical programs. This role involves leading regulatory submissions and engaging with health authorities...Remote job
$189k - $246k
Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute comprehensive regulatory strategies supporting clinical... .... Applicants should have significant experience with global health authorities, ideally with a background in oncology...Remote job$189k - $246k
Travere Therapeutics is hiring a Director of Regulatory Affairs Strategy in New York, NY, responsible for developing and executing global regulatory strategies for drug development programs. This role involves significant experience with health authorities and requires...Remote job$200k - $250k
A leading regulatory consulting firm is seeking a Senior Director for Regulatory Strategy Consulting to architect global regulatory strategies and lead cross-functional teams. The role demands... ...and client engagement. This is a remote position but may require travel. Full-...Remote jobFull time$189k - $246k
Travere Therapeutics, located in Boston, is seeking a Director of Regulatory Affairs Strategy. The role involves developing and executing global regulatory strategies for Phase 2 and Phase 3 drug development programs. As the regulatory lead, you will ensure compliance,...Remote job$210k - $235k
Vor Bio is looking for a Director of Regulatory Strategy in Boston, MA. This role involves global leadership in regulatory strategy for developmental programs in immunology. The Director will work closely with cross-functional teams to ensure compliance and effectively...Remote jobFlexible hours- Regulatory CMC Manager Cell and Gene Therapy Updated: Yesterday Location: Remote, DC, Colombia Job ID: 25108926-OTHLOC-7352-2DR Description Regulatory CMC Manager... ...execution of cell and gene therapy global regulatory CMC strategies for marketed and development products....Remote workContract work
$210k - $235k
...development, commercial strategy, and beyond. Innovation:... ...beyond one indication—a therapy that has already shown consistent... ...and geographies. The Director, Regulatory Strategy provides global regulatory leadership and... ...authorities . Remote role; occasional travel required...Remote workWorldwideFlexible hours$211.5k - $258.5k
...on developing and delivering category‑leading precision therapies to transform the lives of people living with autoimmune... ...diseases can live life fully. Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading...Local areaFlexible hours2 days per week- Vertex Pharmaceuticals Incorporated in Washington, DC is seeking an Executive Director, Regulatory Strategy. The role leads development and execution of global regulatory strategies for the Type 1 Diabetes portfolio, guiding senior cross-functional teams and shaping franchise...
$135k - $190k
...time to get life-saving therapies to patients faster;... ...with many of our 3,300+ global colleagues coming from... ...disciplined contract strategy, bid and tender excellence... ...reports to the Senior Director, Global Commercial... ...Transformationand will be fully remote. In this role, you...Remote workFull timeContract workPart timeWork from homeFlexible hours- ...1pm est. Location: REMOTE EST Salary: MarketJob... ...Title / Position:Director/Senior Director Regulatory AffairsDepartment:Regulatory... ...and serve as a global liaison to regulatory authorities for gene therapy productsMajor... ...global regulatory strategies that support efficient...Remote work
$116k - $151k
...RemoteBe a part of a global team that is inspired... ...deliver life-changing therapies to people living with... ...Summary:The Manager, Regulatory Affairs provides regulatory... ...of global regulatory strategies from development through... ...expected to be 100% remote.Total Rewards Offerings...Remote workFull timeContract workTemporary work- ...mission: to advance gene therapy and change the lives... ...Position Summary The Director, Regulatory Affairs will serve as... ....S.-based regulatory strategy lead for assigned... ...responsibility for driving global regulatory strategy... ...Affairs and work remotely from within the United...Remote workWork at officeLocal area
$220k - $250k
...Director, Regulatory CMC Remote Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering... ...lymphocyte (TIL) therapy for people with... ...therapy, including gene-edited cell therapy,... ...on global regulatory strategy, regulatory submissions...Remote workWork at office
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