Global Regulatory Leader for Gene Editing Therapies
Editas
Editas Medicine seeks a Vice President, Regulatory Affairs to lead our global regulatory function for in vivo gene editing therapies from discovery through regulatory submissions. Based in Cambridge, MA, this hands-on leader will shape strategy and build processes in a lean organization. You will guide interactions with health authorities, manage INDs/CTAs, and coordinate evidence-generation strategies with cross-functional teams to keep development on a compliant and accelerated path. #J-18808-Ljbffr Editas
$225k - $260k
...driving force behind everything we do. As a global leader with the most comprehensive portfolio... ...of next-generation, life-changing therapies. Surrounded by a diverse and collaborative... ..., Digital Pathology, R&D, Clinical, Regulatory, Commercial, Sales and Marketing teams...RegulatoryFull timeRemote workWork from homeFlexible hours$177k - $278.08k
...organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic... ...impact on patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory...RegulatoryMinimum wageLocal areaRemote workWorldwide- ...next generation oral and injectable therapies that prioritises tolerability, durability... ...medical innovation? As the Senior Global Medical Affairs Leader for MASH, you'll play a pivotal role... ...of healthcare system pathways, regulatory landscapes, market access, and competitive...RegulatoryFull timeWorldwideRelocation package
$212k - $333.19k
...shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our... ...leadersCommitted to simultaneously driving regulatory approval as well as launch and... ...molecules or novel modalities such as Cell Therapy or Gene Therapy, large scale programs...RegulatoryMinimum wageWork at officeLocal areaRemote workNight shift- ...palindromic repeats (CRISPR)-based gene editing therapies to transform lives of... ...be medical history. As a leader in this field, our responsibility... ...is offering a 2-year Global HEOR and Evidence Strategy... ...global epidemiology to support regulatory interactions and...RegulatoryWork experience placementH1bVisa sponsorshipWork visa
- ...AstraZeneca seeks a Senior Global Medical Affairs Lead for its Cardiovascular & Renal therapy area. This executive role drives medical strategy, evidence generation... ...Expertise in healthcare system pathways, regulatory landscapes, and external stakeholder engagement...Regulatory
$154.4k - $242.55k
...the best of my knowledge.Job DescriptionThe Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new... ...Translational Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived...RegulatoryMinimum wageLocal area$237.7k - $356.5k
...Director, CMC Product Leader (T1D) will lead the Chemistry... ...team supporting cell therapy products within... ...Biopharmaceutical Sciences - Cell & Gene Therapy. The role is... ...transfer, validation, regulatory submission, and... ..., quality systems, and global regulatory expectations...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week- ...seeking to recruit an experienced Global Asset Lead (GAL) to take end‐... ...the efforts of Clinical, Regulatory, CMC, Medical Affairs, and... ...Functional Liaison*** **Project Team Leader:** Lead the GPT as the... ...indications, earlier lines of therapy, and novel combination regimens...RegulatoryShift work
- ...Vice President, Regulatory Affairs About the Company Innovative gene editing company Industry Biotechnology... ...to lead and build the global regulatory function... ...gene editing therapies. The successful candidate... ...hands-on role requires a leader who can define and...Regulatory
- ...Prime Medicine seeks a Vice President of Regulatory Affairs to lead global regulatory strategy for a diverse pipeline of gene editing and advanced therapy programs. The role involves directing submissions to health authorities, managing regulatory compliance, and building...Regulatory
$190k - $240k
...Americas Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare... ...Commercial, etc.· Ensure compliance with internal and external regulatory and legal guidelines.· Maintain clinical, scientific, and...RegulatoryFull timeLocal areaRemote work$212k - $318k
...multiple breakthrough medicines for Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-thalassemia and Journavx, a... ...Lead within our Cell and Gene Therapy (CGT) portfolio in the Global Value and Access Strategy (GVAS) team.The individual will be...Full timeSummer workRemote workFlexible hours2 days per week$327.1k - $399.9k
...develop curative genome editing treatments that can... ...Title Vice President, Gene Editing Core Job Summary... ...genome editing therapies. This role will oversee... ...organizational goals. As a senior leader, this incumbent is... ...Works with clinical, regulatory, and product...RegulatoryFull timeLocal area$307k - $325.35k
...leading engineered cell therapy company pioneering... ...proprietary CELL+GENE™ platform, we... ...technology and gene editing to deliver... ...President, Program Team Leader is the single point... ...clinical, regulatory, CMC, nonclinical,... ...~5+ years leading global cross-functional program...RegulatoryWorldwideShift work$313k - $348k
...delivering the next generation of gene editing therapies to patients. The Company is... ...clinical development and regulatory path, and each expected to... ...will partner closely with leaders across Research, CMC,... ...that will shape regulatory global strategy from early development...RegulatoryFull timeContract workTemporary work$149k - $166k
...and delivering the next generation of gene editing therapies to patients. The Company is leveraging... ...clearly defined clinical development and regulatory path, and each expected to provide the... ...teams to ensure submissions to global health authorities (including the FDA...RegulatoryFull timeTemporary work- ...Vice President, Regulatory Affairs At Editas... ...CRISPR/Cas9 genome editing systems into a... ...potential of CRISPR gene editing to transform... ...and build the global regulatory function... ...vivo gene editing therapies, serving as the company... ..., this hands-on leader will oversee all...Regulatory
- Sanofi seeks a Global Safety Officer in Cambridge, MA / Morristown, NJ to lead pharmacovigilance and safety analyses across development... .... You will guide risk management, signal detection, and regulatory submissions while collaborating with partners and Health Authorities...Regulatory
- ...leading biotech company in Cambridge is seeking a Director of Global Scientific Communications to lead the development of innovative... ...managing complex data communications, collaboration with clinical and regulatory teams, and mentoring global teams. Ideal candidates possess...Regulatory
- Korro seeks a senior clinical operations leader to drive early phase global trials in rare diseases. You will oversee CROs, study design, budgets,... ...role requires 8+ years in clinical development, strong regulatory knowledge, and a track record delivering FIH studies. Travel...Regulatory
$206.99k - $310.49k
...responsible for providing strategic direction and leading the global drug development with one late stage asset that can have multiple... ...strategy, including indication sequencing and the overall regulatory and CMC strategy to support all the indications under development...RegulatoryFull timeTemporary workWork at officeLocal areaWorldwide- PROMETRIKA, a full-service CRO, seeks a Manager, Medical Writing to oversee the creation of regulatory documents for global drug development programs. The role includes writing and editing protocols, CSRs, and submissions, and supervising junior writers and contractors. The...RegulatoryFor contractors
- Sanofi US Services is seeking a Real World Evidence Strategy Lead to shape RWE strategy across global franchises. You will translate medical needs into evidence for regulatory and access decisions and lead end-to-end real-world studies with cross-functional teams. The...Regulatory
$144.8k - $217.2k
...to discover and develop therapies that take aim at... ...such as tumor suppressor gene loss and their contribution... ...support trial execution, regulatory compliance, and... ..., eCOA specifications, edit checks, Data Management... ...activitiesExperience working within global clinical development...Regulatory$268.2k - $402.2k
...Vertex Pharmaceuticals seeks an experienced regulatory leader to develop and implement global regulatory strategies for Type 1 Diabetes programs. This executive role manages a team of regulatory professionals across multiple development stages and represents regulatory...Regulatory- ...Strategic executive leader responsible for defining and executing Cell & Gene Therapy quality vision, operating model, and organizational strategy... ...operating models supporting portfolio growth, global commercialization, and regulatory compliance Lead quality oversight for...Regulatory
$145k - $170k
...clinical stage, next-generation gene editing company based in Cambridge,... ...management of US and global clinical trials (delivered on... ...quality)Experience in ethics and regulatory dossier submissions (e.g.,... ...skillsKnowledge of mRNA, RNAi, gene therapy or gene editing therapeutics...RegulatoryContract work$275.13k - $336.27k
...develop curative genome editing treatments that can... ...the Senior Director, Global Brand and US... ...of one of Intellia’s gene editing therapies currently in late-stage... ...Access, Medical, Legal, Regulatory, Compliance, and IT.... ...with external thought leaders and medical societies...RegulatoryFull time$177k - $278.08k
...organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic... ...therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices...RegulatoryMinimum wageLocal areaRemote workWorldwide
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