Senior Director, Gene Therapy Regulatory Strategy
BioSpace
BioSpace is seeking a Senior Director of Regulatory Affairs in Boston. The role involves planning and executing regulatory strategies for gene-editing programs, managing submissions, and serving as a key contact with regulatory authorities. This position requires a Bachelor's degree and over 10 years of experience in the pharmaceutical or biotechnology industry, with at least 5 years in regulatory affairs. Candidates with complex biologics experience are preferred. #J-18808-Ljbffr BioSpace
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...leading engineered cell therapy company pioneering a... ...Utilizing our proprietary CELL+GENE™ platform, we direct... ...Clinical Development, Regulatory Affairs, Quality, and... ...needs. Responsibilities Strategy & Leadership - Define... ...development, with senior leadership experience in...SeniorRegulatoryWorldwide$148k - $222k
...The Quality Systems Associate Director supports strategic design of... ...across the Vertex Cell and Gene Therapy (VCGT) organization. The... ...facilitate harmonization of strategy, procedures, and processes related... ...with procedures and regulatory requirements. Monitor and support...RegulatoryLocal areaRemote workFlexible hours2 days per week$174k - $212k
...for an experienced Associate Director of Clinical Data Management to guide the clinical data strategy for gene editing programs. This role... ...management activities to ensure regulatory compliance and clinical data... ..., particularly in gene therapy and rare disease clinical trials...Regulatory- ...advocacy groups in all of our clinical and regulatory development strategies. With a keen understanding that... ...challenges to make much-needed therapies available to patients. Nimble and dauntless... ...’ lives. About the role The Director, Global Patient Advocacy, will work...SeniorRegulatoryLocal area
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Job Title Senior Director, US Rare Disease Value and Access Location Cambridge... ...own payer-focused access strategy across a $2.2B business with... ..., including a landmark AATD therapy in 1H 2027. You will lead... ...position. Anticipate changes in regulatory and reimbursement landscape;...SeniorRegulatory$195k - $275k
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...clinical and commercial product. As the Senior Director, Late-Stage Cell Therapy Process Development, you will... ..., robustness, quality and regulatory compliance. Lead process characterization... ...and execute a comparability strategy for pivotal process changes. Enable...SeniorRegulatory- Senior Manager/Associate Director, Global Regulatory Affairs CMC About the Opportunity A growing biotechnology company... ...Affairs CMC to support regulatory strategy and execution across the development... ...of innovative biologic therapies. This individual will play a key...SeniorRegulatory
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Senior Director, Biostatistics Beeline Medicines is a clinical‑stage biotechnology... ...category‑leading precision therapies to transform the lives of... ...expert - owning statistical strategy and methodology for assigned... ...a key statistical voice in regulatory interactions and submissions...SeniorRegulatoryLocal area2 days per week$137k - $215.27k
JobRx, Inc. is seeking a Manager Regulatory Lead based in Boston, MA to oversee and implement regulatory strategies for plasma-derived therapies. This role involves coordinating the Global Regulatory Team, ensuring compliance with FDA requirements, and managing submissions...SeniorRegulatory$267k - $285k
...Somerville, Massachusetts is seeking a Senior Director, Process Development to provide leadership in process development for gene therapies. The role involves overseeing workflows... ...collaborating across teams, and ensuring regulatory compliance. Candidates should possess a...SeniorRegulatory$190k - $240k
Orchard Therapeutics - U.S. is seeking a Regulatory Science expert to lead US regulatory strategy for gene therapy. The role involves collaboration with global teams to expedite FDA submissions while ensuring compliance across clinical development. Candidates should have...Regulatory$71.25k - $161.7k
...on developing one‑time gene editing medicines for... .... Verve is seeking a Senior Associate, Quality Control... ...develop qualification strategies, and ensure reference... ...and other applicable regulatory requirements. Basic... ...Previous experience in gene therapy product testing. 5+...SeniorRegulatoryPermanent employmentFull timeH1bWork at officeVisa sponsorshipWork visaFlexible hours- Sana Biotechnology, Inc. is hiring a Senior Director for Late-Stage Cell Therapy Process Development in Cambridge, MA. You'll oversee the development... ...role involves managing a team, ensuring compliance with regulatory standards, and leading process validation activities....SeniorRegulatory
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...developing novel precision therapies to treat a broad range of patients... ...capabilities. The Senior Manager partners closely with... ...leveraging data and segmentation strategies. Promotional Review &... ...management. Deep understanding of regulatory requirements, including FDA,...SeniorRegulatoryContract workTemporary workWork at officeLocal areaImmediate start$177k - $308k
...Lilly and Company is committed to using its innovation-based strategy to discover, develop and deliver innovative medicines that help... ...cross‑functional partners (e.g. Clinical Operations, Statistics, Regulatory Affairs) to ensure seamless AI integration across R&D and...SeniorRegulatoryFull timeFlexible hours- VCLS, a regulatory consulting firm, seeks an experienced Senior Director or Executive Director of US Regulatory Strategy in Boston to provide strategic regulatory guidance to biotech and... ...clients developing innovative therapies. Lead US/global regulatory strategy,...Regulatory
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...potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program,... ...this opportunity as we are! Your Impact As Associate Director, Regulatory Strategy, you'll help define the regulatory path for our small-molecule...RegulatoryFull timeWork at officeLocal areaImmediate start$192k - $208.5k
...delivering category‑leading precision therapies to transform the lives of people... ...life fully. Job Summary The Associate Director, Regulatory Strategy is a key member of the Regulatory Affairs... ...clearly to program teams and senior leadership. Lead preparation and execution...RegulatoryLocal area2 days per week$210k - $225k
...leading engineered cell therapy company using its unique CELL+GENE™ platform to direct cellular... ...disease areas. The Director of Imaging and... ...Develop translational strategies designed to support clinical... ...development plans, the regulatory path, and product commercialization...Regulatory- ...and execution of distribution strategies supporting nephrology... ...competitive dynamics, and adapt to regulatory or legislative changes impacting... ..., high‑touch, and complex therapy models commonly seen in nephrology... ...strategic recommendations to senior leadership and cross‑...Regulatory
$210k - $235k
...clinical 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... ...a key regulatory advisor to senior leadership and cross‑...SeniorRegulatoryRemote workWorldwideFlexible hours$152.8k - $283.4k
...Cambridge, MA Internal: Associate Director LI#-Hybrid The Associate Director, Clinical Data Strategy is a strategic leadership role... ...scientific, operational, and regulatory objectives across the TM... ...consistency across studies/programs/therapy areas, ensuring prioritization...Regulatory$152.8k - $283.4k
Role The Associate Director, Clinical Data Strategy is a strategic leadership role within Translational Medicine... ...with scientific, operational, and regulatory objectives across the TM portfolio.... ...consistency across studies/programs/therapy areas, ensuring prioritization, risk...Regulatory
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