Director, Global Regulatory CMC - Gene Therapy
Jobtailor
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 cross-functional teams through complex regulatory interactions and ensure technical accuracy of CMC documentation. The role requires 5+ years in regulatory CMC for ATMPs, strong leadership, and deep knowledge of ICH guidelines, #J-18808-Ljbffr Jobtailor
- Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities....Suggested
- 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...SuggestedFull time
- 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
$177k - $278.08k
...unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic... ...to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$238k - $374k
...organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four... ...-changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide...SuggestedMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$163.5k - $281.6k
...a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting-edge gene therapy portfolio. This role will be critical... ..., ensuring compliance with global health authority requirements.Job ResponsibilitiesDevelop...For contractorsWork at officeFlexible hours$204k - $245k
...become part of a company that’s pursuing curative gene therapies to give patients and their families more days... ...every challenge with radical care. The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved and late...Full timeWork at officeFlexible hours3 days per week- Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions Lead and manage the preparation, authoring, and review of high-quality CMC sections for all regulatory submissions...For contractorsWork at office
$212k - $318k
...medicines for Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-... ...reach patients faster than ever before.The Director, T1D will serve as a T1D Market Access... ...and Gene Therapy (CGT) portfolio in the Global Value and Access Strategy (GVAS) team....Full timeSummer workRemote workFlexible hours2 days per week$170k - $220k
Associate Director, Regulatory CMC - Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision... ...focused on advancing a portfolio of gene therapy candidates targeting rare... ...collaborative team with a goal to develop global regulatory CMC experience in gene therapy...Full timeTemporary workRemote workFlexible hours$182k - $275k
Company OverviewRhythm is a global, commercial-stage biopharmaceutical company committed... ...-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s),... ...more patients and developing novel therapies for other rare neuroendocrine diseases,...Work at office- ...Associate Director, Regulatory Affairs CMC Founded over a decade ago, CRISPR Therapeutics... ...developing transformative gene-based medicines for serious... ...world's first CRISPR-based therapy, approved for eligible... ...collaboration with CMC and global development teams, and with...Contract workRemote work
$238k - $374k
...all information I submit in my employment application is true to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused company that will inspire you and support your career? Join...Minimum wageTemporary workLocal areaRemote work- Vertex Pharmaceuticals Inc is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies and submissions across small molecule programs. The role emphasizes strategic leadership, Health Authority...
$190.4k - $285.6k
...Director, Regulatory Affairs CMCSkip to main content#Director, Regulatory Affairs CMC page is loaded## Director, Regulatory Affairs CMCApplylocations... ...developing and executing global regulatory strategies... ...of investigational therapies across a range of modalities...Summer workRemote workFlexible hours2 days per week$268.2k - $402.2k
## Executive Director, Regulatory Strategy, Cell & Gene TherapyApplylocations: Boston, MA: Washington, DCtime type... ...and implementation of innovative global regulatory strategies for product development... ...pipeline of investigational therapies across a range of modalities in...Summer workLocal areaRemote workFlexible hours2 days per week$211.5k - $258.5k
...delivering category‑leading precision therapies to transform the lives of people... ...can live life fully. Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing... ..., ensuring alignment with clinical, CMC, and non‑clinical development...Local areaFlexible hours2 days per week$174.5k - $274.23k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts... ...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant... ...with strong practical experience with global HA requirements, beyond EU/US, who has...Minimum wageTemporary workLocal areaRemote workWorldwide- ...Pharmaceuticals is seeking an Associate Director, Global Submission Management in... ...lead a portfolio of global regulatory submissions across... ...including Pulmonary or Cell & Gene Therapy areas. You will partner with... ...Global Regulatory Strategy, CMC, Labeling, Publishing, and Advertising...
$200k - $220k
Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe... ...potential beyond one indication - a therapy that has already shown consistent... ..., through clinical development and global registration. The candidate must be...Contract workWorldwideFlexible hours$242k - $313.5k
...delivering category‑leading precision therapies to transform the lives of people... ...life fully. Job Summary The Senior Director, Regulatory Affairs CMC - Biologics provides senior‑level scientific... ...in alignment with FDA, EMA, and global Health Authority expectations for...Local areaFlexible hours2 days per week$155k - $190k
...committed to our mission of developing therapies that give people the power to... ...our team. What You’ll Do The Associate Director, Global Regulatory Labeling and Ad Promo will be initially... ...management Collaborate with clinical, CMC, medical, safety, device engineering,...Full timeLocal areaFlexible hours3 days per week$166.4k - $249.6k
...General Summary The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and... ...has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases...Summer workRemote workFlexible hours2 days per week$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO&T function... ...ATMPs in Biogen’s portfolio. Your role encompasses global, regional, and local accountability for all therapeutic...Full timeTemporary workLocal area$177k - $278.08k
...organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic... ...bring life-changing therapies to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible for developing...Minimum wageTemporary workLocal areaRemote workWorldwide$142.5k - $256.5k
The RoleThe Associate Director, Global Regulatory, CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing...Permanent employmentFull timeWork at officeWork from home$290k - $323k
...a world leading oncology company bringing the next wave of therapies for cancer patients. The Company's clinical-stage pipeline... ...LinkedIn and X. Responsibilities Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs, BLAs, MAAs etc.) through product...Contract workTemporary workFor contractorsFlexible hours- Vertex is seeking an Associate Director of CMC to lead global regulatory strategies for biologics, author submissions, and interface with health authorities, leveraging AI-enabled tools to enhance document quality and efficiency. This role requires 8+ years in pharma/biotech...
- Rhythm Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory chemistry, manufacturing, and controls deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical...
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth... ...to role: Are you ready to set the global regulatory vision for pioneering... ...regulatory objectives with clinical, CMC, safety and commercial strategies....Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week
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