Global Director, Cell Therapy Regulatory Strategy
AstraZeneca GmbH
AstraZeneca GmbH in Boston, MA is seeking a Director of Regulatory Affairs Strategy for Cell Therapy to lead global regulatory strategy across oncology, immune-mediated and rare diseases. You will drive Health Authority engagements, submissions, and labeling, mentor cross-functional teams, and ensure data-driven decisions while delivering therapies to patients with speed and rigor. This role requires an advanced degree and 5–8 years in regulatory affairs with global experience, strong #J-18808-Ljbffr AstraZeneca GmbH
$171.62k - $257.43k
...groundbreaking clinical studies? As a Global Study Director (GSD), you will play a pivotal role in the Cell Therapy Clinical Operations... ...compliance with SOPs, regulatory requirements, and ICH/GCP guidelines... ....- Collaborate to establish strategies for increasing efficiency of...RegulatoryPermanent employmentContract workTemporary workFixed term contractWork at officeFlexible hours3 days per week- ...delivers life-changing therapies for people with serious... ...have high unmet need. As a global leader in the biology of... ...(TGFβ) superfamily of cell proteins and named for the... ...Summary of Position The Director or Senior Director, Regulatory Strategy, reporting to the SVP,...RegulatoryWork at officeLocal areaShift work
$163.2k - $244.8k
## Associate Director, Global Submission ManagementApplylocations: Boston... ...of a portfolio of global regulatory submissions across... ...role will be Pulmonary or Cell & Gene Therapy.This role ensures routine,... ...alignment with global regulatory strategies and operational objectives...RegulatorySummer workRemote workFlexible hours2 days per week$148k - $222k
...Quality Systems Associate Director supports strategic... ...across the Vertex Cell and Gene Therapy (VCGT) organization.... ...facilitate harmonization of strategy, procedures, and... ...with procedures and regulatory requirements. Monitor... ...governance. Collaborate with Global Process owner to...RegulatoryLocal areaRemote workFlexible hours2 days per week- ...Executive Director, Regulatory Affairs Strategy, Cell & Gene Therapy About the Company Respected biopharmaceutical company Industry Pharmaceuticals... ...biopharmaceutical innovation research and development and global business Business Classifications B2B...RegulatoryFlexible hours
- ...Cystic Fibrosis (CF) and a gene therapy for sickle cell disease and beta-... ...evidence plans to support global market access and value Develop... ...pricing and market access strategy, payment models and negotiation... ..., product development, regulatory affairs). Collaborate closely...RegulatoryRemote workFlexible hours
- ...and Controls (CMC) to define and execute global CMC strategy across biologics, oligonucleotides, combination products, and cell & gene therapies. You will lead phase-appropriate programs from early development through regulatory readiness, partnering with Regulatory, clinical...Regulatory
- ...) is seeking an Associate Director for Global Submission Management to oversee strategic global regulatory submissions across development... ...emphasis on Pulmonary or Cell & Gene Therapy areas. You will ensure... ...aligned with global regulatory strategies. The role leads cross‑...Regulatory
$155.7k - $233.5k
Job Description The Strategy & Operations Associate Director is a strategic leadership role responsible for... ...and disease area strategies into Cell & Genetic Therapy (CGT) Research‑specific execution... ...Company Information Vertex is a global biotechnology company that invests...Remote workFlexible hours2 days per week$250k - $300k
...the potential of engineered cells as medicines, who want to... ...product. As the Senior Director, Late-Stage Cell Therapy Process Development, you will... ..., robustness, quality and regulatory compliance. Lead process... ...and execute a comparability strategy for pivotal process...Regulatory- Vertex Pharmaceuticals Inc (US) in Boston is seeking a Regulatory Strategy Associate Director to oversee the development of global regulatory strategies for their portfolio. The role involves leading regulatory submissions and mentoring team members on regulatory frameworks...Regulatory
$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MD Boston, MA South San Francisco, CA Santa Monica, CA Introduction to role: Are you ready to steer global regulatory strategy for cell therapies that redefine standards...RegulatoryHourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week$150k - $225k
In AstraZeneca's Cell Therapy division, we follow the science to explore... .... The Associate Director - Territory Operations Manager... ...Operations Directors (RODs) on site strategy, leads research and internal... ...Sites. Operate within regulatory/accreditation standards (e.g...RegulatoryTemporary workLocal area$211.91k - $256.79k
## Associate Director, Global Clinical Science, NeuroscienceCambridge Crossing - MA - USFind... ...production line to the latest breakthroughs in cell therapy, this is work that transforms the... ...(CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Sana Biotechnology, Inc. is hiring a Senior Director for Late-Stage Cell Therapy Process Development in Cambridge, MA. You'll oversee the development... ...involves managing a team, ensuring compliance with regulatory standards, and leading process validation activities. Ideal...Regulatory
- ...leading biotechnology company in Boston seeks a Senior Director of Manufacturing Technical Sciences Quality Assurance. This hybrid role involves overseeing quality for cell and genetic therapies, ensuring regulatory compliance, and leading a team across all stages of...RegulatoryFlexible hours
$192k - $288k
...develop, and deliver therapies to those living with serious... ...(IgAN), additional B cell-mediated diseases, and... ...field reimbursement strategies, fostering cross-... ...ensuring compliance with regulatory standards. The Area Leader... ...Vertex is a global biotechnology company...RegulatorySummer workWork at office$177k - $278.08k
...that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic... ...therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and...RegulatoryFull timeTemporary workLocal areaWorldwide- ...Biopharmaceutical Sciences - Cell & Gene Therapy (CGT) Manufacturing and... ...Engineering. Ensure compliance with global regulatory requirements, maintain... ...training. Reports to the Director, CGT Engineering... ...GMP manufacturing training strategy using competency-based training...Regulatory
$174k - $212k
...generation of gene editing therapies to patients. The... ..., organs and cell types. Prime... ...clinical development and regulatory path, and each... ...experienced Associate Director of Clinical Data... ...clinical data strategy and execution across... ..., CTAs, BLAs, and global regulatory filings...RegulatoryFull timeTemporary work$170k - $210k
...is seeking an MSAT Associate Director. This role involves leading a... ...responsible for the pancreatic cell maturation and aggregation... ...years of experience in cell therapy manufacturing. The position requires... ...skills along with regulatory compliance. The base pay range...Regulatory$190k - $252k
...together pioneers in cell and gene therapy, guided by extraordinary... ...growing team as a Director/Sr. Director, Clinical... ...translating program strategy into an integrated, executable... ...across Clinical, Regulatory, CMC, Nonclinical,... ...as applicable. Lead global cross‑functional team...RegulatoryFlexible hours$225.9k - $338.85k
...Job Title: Senior Director, Translational Medicine B-cell NHL & Leukemia Waltham... ...pivotal biomarker strategies for antibodies,... ...assay development to regulatory submission. Working... ...for inclusion in global submissions. Cross... ...and/or cell therapies is strongly preferred...RegulatoryHourly payTemporary workStart working todayWork at officeFlexible hoursShift work3 days per week$199.5k - $249.4k
...Pharma Co., Ltd. is a global pharmaceutical... ...health, rare diseases, cell & gene therapies, and CNS, aiming to accelerate... ...Leader Liaison Director - Hematology (Enzomenib... ..., and engagement strategy. Build and strengthen... ...with all applicable regulatory, legal and operational...RegulatoryFlexible hoursNight shift- Associate Director, Global Regulatory Affairs, Advertising and Promotion Job Description At Takeda, we are a forward‑looking, world‑class R&D organization... ...that unlocks innovation and delivers transformative therapies to patients worldwide. The Associate Director, Global...RegulatoryFull timeRemote 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,...Regulatory
$199k - $236k
...Therapeutics is seeking an Associate Director, Global Scientific Communications,... ...that support medical strategy and product understanding.... ...Development, Research, Biostats, Regulatory, Legal, and Corporate... ...treatment by enabling immune cell penetration into tumors, reducing...RegulatoryWork at officeLocal area3 days per week- Director, T1D (T1D Market Access Lead) Global Value and Access Strategy (GVAS), Cell and Gene Therapy (CGT) Key Responsibilities Lead payer strategic planning to optimize value and access for early‑stage T1D pipeline assets Develop and refine Market Access strategies and...
$210k - $225k
...AG, is a leading engineered cell therapy company using its unique CELL+GENE... ...disease areas. The Director of Imaging and Biomarkers, Translational... ...to: Develop translational strategies designed to support clinical development plans, the regulatory path, and product...Regulatory- ...in all of our clinical and regulatory development strategies. With a keen... ...challenges to make much-needed therapies available to patients.... ...About the role The Director, Total Rewards will have the... ...opportunity to build and scale the global total rewards program at Zevra...RegulatoryLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Director, Cell Therapy Regulatory Strategy. Be the first to apply!
- compliance director Boston, MA
- regulatory affairs manager pharmaceutical Boston, MA
- senior director regulatory affairs Boston, MA
- senior regulatory manager Boston, MA
- sr. manager regulatory compliance Boston, MA
- corporate compliance manager Boston, MA
- compliance manager Boston, MA
- associate director compliance Boston, MA
- training and compliance manager Boston, MA
- regulatory affairs director Boston, MA

