Regulatory Strategy Executive - Cell & Gene Therapy (Hybrid)
Vertex Pharmaceuticals
Vertex Pharmaceuticals is seeking an Executive Director of Regulatory Strategy for its Cell & Gene Therapy portfolio focused on Type 1 Diabetes. This global leadership role manages a team of regulatory professionals and drives innovative strategies for development and commercialization. A strong track record in pharmacovigilance, submissions, and health authority interactions is essential, with hybrid work options available. #J-18808-Ljbffr Vertex Pharmaceuticals
$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical... ...donations, 401(k) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In...RegulatoryFull timeSummer workLocal areaRemote workFlexible hours2 days per week- ...DescriptionPosition Summary:The Executive Director serves as a... ...and executing the Cell & Genetic Therapies (CGT) Quality vision,... ..., and organizational strategy. The role is... ...challenges, and global regulatory requirements to support... ...life cycle in Cell & Gene therapy and/or...RegulatoryFull timeSummer workFlexible hours
$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...RegulatoryHourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$212k - $318k
...for Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-thalassemia and Journavx... ...in the Global Value and Access Strategy (GVAS) team.The individual will be responsible... ...k) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...SuggestedFull timeSummer workRemote workFlexible hours2 days per week- ...Technical Quality to provide end-to-end QA oversight across cell and gene therapies from development through post-approval. You will establish... ..., lead lifecycle governance, and ensure alignment with regulatory expectations while safeguarding patient safety and product...Regulatory
$176k - $264k
...Associate Director, Cell and Gene Therapy (CGT) will participate... ...the development and execution of HEOR studies in support... ...content expertise to strategy planningApplies best... ...of the legal and regulatory environment of the pharmaceutical... ....Flex Designation:Hybrid-Eligible Or On-Site...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$148k - $222k
...and ensures tactical execution of quality systems, risk... ...across the Vertex Cell and Gene Therapy (VCGT) organization.... ...facilitate harmonization of strategy, procedures and... ...with procedures and regulatory requirements Monitor... ...more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...RegulatoryFull timeSummer workLocal areaRemote workFlexible hours2 days per week- Sana Biotechnology, Inc. is seeking a Senior Director to lead the company’s IP strategy in cell and gene therapy. You will draft and prosecute patents, manage global portfolios, and guide landscape analyses. Collaboration with R&D and external counsel is essential to align...
- ...CRISPR Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive experience in CMC regulatory requirements for biologics and gene therapies...RegulatoryRemote workFlexible hours
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica... ...accelerate access for patients.You will report to the Executive Director, Cell Therapy Regulatory Affairs and act as a...RegulatoryHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$256k - $320k
...we launched our fourth therapy and the first ever gene therapy to treat Duchenne... ...— driving rigorous regulatory-grade deliverables while... ...shaping clinical development strategy — not solely executing within it. The ideal... ...HybridThis position is hybrid, you will be expected...RegulatoryFull timeRemote work$249.4k - $374.2k
...serious diseases. The Executive Director, MSAT will provide... ...our Type 1 Diabetes cell therapy manufacturing network.... ..., Quality, CMC, Regulatory, Supply Chain, and external... ...Responsibilities:MSAT Strategy & Network... ...operating in CMO-centric or hybrid manufacturing models.Pay...RegulatoryFull timeSummer workFlexible hours$252.3k - $378.5k
## Executive Director, Manufacturing Operations... ...Type 1 Diabetes cell therapy programs.This... ...accountable for the strategy, governance, and... ...readiness and support regulatory filings and... ...Experience in cell and/or gene therapy... ...Flex Designation:**Hybrid-Eligible Or On-Site...RegulatoryContract workSummer workRemote workFlexible hours2 days per week- ...Consulting Life Sciences (VCLS) is seeking a Senior Director of US Regulatory Strategy to guide biotechnology and pharmaceutical clients through... ...stage development of biologics, combination products, and gene therapies. The ideal candidate will bring significant experience in...Regulatory
$198k - $297k
...platforms across LC1/2, Vertex's Cell & Gene Therapy (CGT) site. It is also the... ...translator. CGT-specific regulatory and quality compliance is... ..., communication, and executive-level presentation skills.Ability... ...much more.Flex Designation:Hybrid-Eligible Or On-Site...RegulatoryFull timeSummer workLocal areaRemote workFlexible hours2 days per week$235k - $335k
...generation of convenient, highly effective therapies for patients with these conditions.... ...impact:Kymera is seeking a Senior/Executive Director, AI Strategy & Applications to serve as the... ...across Research, Clinical Development, Regulatory/CMC, and G&A to turn scientific and...Regulatory$327.1k - $399.9k
...Title Vice President, Gene Editing Core Job... ...genome editing therapies. This role will oversee... ...the planning, execution, and delivery of projects... ...role will develop strategy, implement, and... ...with clinical, regulatory, and product... ...NGS, ddPCR, single-cell genomics, and spatial...RegulatoryFull timeLocal area$267.91k - $401.87k
Within the AstraZeneca Cell Therapy Enterprise, our ambition is to realize the full potential of cell therapy for people living... ...with AstraZeneca’s Therapeutic Area Units. The Strategy and Commercial Executive Director, Cell Therapy Strategy and Commercial (CTSC),...Full timeTemporary workWork at officeFlexible hours3 days per week$137.8k - $206.8k
...including risk-based audit strategy, quality risk identification... ...position is on-site or hybrid and is not eligible for a fully... ...clinical programs.Support regulatory agency inspections at Vertex... ..., combination products, or cell and gene therapy clinical trials.Experience...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week- ...discover and develop therapies that take aim at... ...tumor suppressor gene loss and their contribution... ...ability of cancer cells to evade immune... ...to serve as Executive Director, Clinical... ...clinical development strategy for an early-stage... ...Pharmacology, Regulatory, Medical Affairs,...Regulatory
$174k - $212k
...Management to guide the clinical data strategy for gene editing programs. This role will involve... ...data management activities to ensure regulatory compliance and clinical data integrity... ...of experience, particularly in gene therapy and rare disease clinical trials. The...Regulatory$318k - $337.5k
## Senior Vice President, Cell Therapy Product Supply OperationsApplyremote... ...stem cell technology and gene editing to deliver... ...readiness. This role oversees the strategy, execution, and continuous improvement... ..., Analytical, Quality, Regulatory, Clinical Operations, Program...RegulatoryContract workWorldwide- ...Cell Therapy Strategy & Commercial Executive Director About the Company Respected biopharmaceutical company Industry Pharmaceuticals Type Public Company Founded 1999 Employees 10,001+ Categories Health and Wellness Medical Pharmaceuticals...
- Genetix Biotherapeutics is looking for a Director, Regulatory CMC to lead global regulatory strategies for gene therapy products. This full-time hybrid position based in Somerville, Massachusetts involves managing post-approval regulatory strategies and ensuring compliance...RegulatoryFull time
- Research Scientist, Cell and Gene Therapy Analytical (Contract) This Research Scientist position will be part of the Analytical Science and... ...study protocols, and technical reports. Prepare and review regulatory filings and responses. Knowledge and Skills: Hands-on experience...RegulatoryContract work
$190k - $240k
...company, is a global gene therapy leader focused on transforming... ...hematopoietic stem cells (HSCs). Orchard has... ...Sr MSL will develop strategy, serve as a team mentor... ...ensure excellence in execution balanced with risk management... ...internal and external regulatory and legal guidelines.·...RegulatoryFull timeLocal areaRemote work$238k - $374k
...delivers transformative therapies to patients. By focusing... ...to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug... ...and robust regulatory strategies for medical devices and drug... ...currently classified as "hybrid" following Takeda's...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$156.6k - $234.8k
...quality oversight for cell and gene therapy programs across... ...ensuring alignment with regulatory expectations and... ...to support program execution and governance, ensuring... ...frameworks, standards, and strategies to ensure products... ....Flex Designation:Hybrid-Eligible Or On-Site...RegulatoryFull timeContract workSummer workRemote workFlexible hours2 days per week$123.12k - $205.2k
...for?GHD Advisory is seeking an Executive Advisor - Water Economics & Infrastructure Investment Strategy to lead and grow our water... ...maintain relationships with regulatory agencies, municipal utilities... ...experience and location.Our Hybrid Work Model: Be part of the dynamic...RegulatoryWork at officeLocal areaWorldwide3 days per week$160.6k - $240.8k
...the development and execution of audit/quality plans... ...preparedness strategies and activities. This... ...drive compliance with regulatory requirements to ensure... ...clinical studies or Cell and Gene Therapy is advantageous.Professional... ....Flex Designation:Hybrid-Eligible Or On-Site...RegulatoryFull timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week
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