Director, Regulatory CMC - Gene Therapy Strategy
Eli Lilly and Company
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. You will author and review high‑quality CMC submissions and serve as the main liaison with health authorities globally. This role requires 5+ years in regulatory CMC for ATMPs, strong leadership, and the ability to collaborate across R&D, manufacturing, quality, and clinical teams in a fast‑paced environment. #J-18808-Ljbffr Eli Lilly and Company
- 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
$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical regulatory knowledge and advanced drug development expertise in Type 1 Diabetes (T1D). The incumbent will be responsible...SuggestedFull timeSummer workLocal areaRemote workFlexible hours2 days per week$163.5k - $281.6k
...join us. Eli Lilly and Company is seeking 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 in shaping the regulatory path for...SuggestedFor contractorsWork at officeFlexible hours$204k - $245k
...Director, Regulatory CMC Somerville, MA At Genetix Biotherapeutics every role has meaning,... ...a company that's pursuing curative gene therapies to give patients and their families... ...execution of global CMC regulatory strategies for approved and late-stage gene therapy...SuggestedFull 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
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction... ...and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.Evidence and...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$212k - $318k
...medicines for Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-... ...patients faster than ever before.The Director, T1D will serve as a T1D Market Access... ...portfolio in the Global Value and Access Strategy (GVAS) team.The individual will be...Full timeSummer workRemote workFlexible hours2 days per week$182k - $275k
...high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in alignment with strategies established by Global Regulatory Affairs and... ...to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including...Work at office$177k - $278.08k
...innovation and delivers transformative therapies to patients. By focusing R&D... ...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...develops the regulatory CMC strategy and leads the execution of...Minimum wageTemporary workLocal areaRemote workWorldwide$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA... ...and deliver life-changing therapies to people living with rare... ...Summary: The Director, Regulatory Affairs Strategy is responsible for developing... ...Affairs, Biostatistics, CMC, Quality, Nonclinical, Commercial...Temporary workLocal areaRemote workWeekend work- ...developing transformative gene-based medicines... ...CRISPR-based therapy, approved for eligible... ...to the Head of Regulatory Affairs, you will... ...As the Regulatory CMC lead for these programs... ...Regulatory strategies where little precedent... ...: ~ Associate Director: ~12+ Years of relevant...Contract workRemote work
$238k - $374k
...innovation and delivers transformative therapies to patients. By focusing R&D... ...to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination... ...innovative and robust regulatory strategies for medical devices and drug-device...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide- 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...
$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... ...to R&D, Clinical, Quality, CMC, Commercial, and represents...Remote workWorldwideFlexible hours- 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...
$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... ...programs, ensuring alignment with clinical, CMC, and non‑clinical development...Local areaFlexible hours2 days per week$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... ...executing biologics CMC regulatory strategies from early clinical development...Local areaFlexible hours2 days per week- ...innovation and delivers transformative therapies to patients. By focusing R&D... ...therapies to patients worldwide. The Director, Regulatory Site CMC ensures efficient and compliant management... ...and communicate regulatory strategy to drug development, registration, and...Local areaWorldwide
$200k - $220k
Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe... ..., clinical development, commercial strategy, and beyond. Innovation: Work on a... ...potential beyond one indication - a therapy that has already shown consistent...Contract workWorldwideFlexible hours$190.4k - $285.6k
Director, Regulatory Affairs CMCSkip to main content#Director, Regulatory Affairs CMC page is loaded## Director, Regulatory Affairs CMCApplylocations... ...global regulatory strategies across multiple investigational... ...of investigational therapies across a range of modalities...Summer workRemote workFlexible hours2 days per week$190k - $215k
...revolutionize the development of small molecule therapies. We are excited about the potential... ...as we are! Your Impact As Associate Director, Regulatory Strategy, you'll help define the regulatory... ...team members including clinical, CMC, clinical pharmacology, and...Full timeWork at officeLocal areaImmediate start$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...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 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, driving the regulatory strategy for biologics and ATMPs in Biogen’s portfolio. Your role encompasses global, regional...Full timeTemporary workLocal area$166.4k - $249.6k
...Summary The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products... ...a robust clinical pipeline of investigational therapies across a range of modalities in other serious...Summer workRemote workFlexible hours2 days per week$200k - $300k
...that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high... ...ScholarRock and on LinkedIn. Summary of Position The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global Head of Regulatory Affairs...Work at officeLocal areaShift work$224.9k - $404.6k
Moderna is seeking a regulatory CMC expert to manage a team at their Norwood, MA site. This key leadership role involves overseeing the product strategy for all portfolio products, managing regulatory submissions, and ensuring adherence to quality standards. Ideal candidates...- Vertex Pharmaceuticals in Boston seeks a Director, CMC to lead global regulatory strategies for the small molecule portfolio, overseeing submissions and Health Authority interactions. The role drives governance, mentors Regulatory CMC staff, and champions AI-enabled capabilities...
- ...seeks a Chemistry Manufacturing Controls Manager to oversee regulatory CMC submissions and strategic interactions with agencies. You will... ...with development and manufacturing teams to shape global CMC strategies for investigational and marketed products, while supporting inspections...Remote work
- Voisin Consulting Life Sciences (VCLS) is seeking a Senior Director of US Regulatory Strategy to guide biotechnology and pharmaceutical clients... ...stage development of biologics, combination products, and gene therapies. The ideal candidate will bring significant experience...
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