Director, Regulatory Strategy - Cell Therapy (Global)
AstraZeneca
AstraZeneca is seeking a Director of Regulatory Affairs Strategy for cell therapy in the United States. The role focuses on shaping global regulatory strategy for CGT programs spanning oncology and immune-mediated diseases, translating breakthrough science into timely approvals and competitive labeling. You will lead cross-functional teams, partner with senior leaders, and manage Health Authority interactions from expedited designations to major submissions, ensuring patient value and global
#J-18808-Ljbffr$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care...SuggestedHourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- ...Scorpion Therapeutics is seeking a Director of Regulatory CMC for Cell Therapy to lead global regulatory strategy and submissions across development and lifecycle stages. The role focuses on cell therapy programs, with emphasis on advanced therapies and biologics, requiring...Suggested
$206.99k - $310.49k
...OncologyGlobal Programme Management(Cell Therapy) Gaithersburg, MD,... ...MA will also be considered Global Portfolio & Project Management... ...week in office The Senior Director, OncologyGlobal Project Management... ...brand strategy and deliverthe approved project...SuggestedTemporary workWork at officeFlexible hoursShift work3 days per week$267.91k - $401.87k
...Within the AstraZeneca Cell Therapy Enterprise, our ambition istorealizethe full... ...Therapeutic Area Units. The Strategy and Commercial Executive Director Cell Therapy Strategy and Commercial... ...Cell Therapy. You will lead global commercial and strategic initiatives...SuggestedTemporary workWork at officeFlexible hours3 days per week$267.91k - $401.87k
...AstraZeneca seeks an executive director to shape strategy and drive commercial initiatives for cell therapy across defined disease areas. This role leads end-to-end portfolio... ...strategy, competitive intelligence, and global commercial execution, reporting to the VP of Cell...Suggested$210.86k - $242.79k
Director, Patient Services Strategy, US Cell & Gene Therapy Office Location: Gaithersburg, MD (3 days minimum per week) Remote is not available for this role. The... ...strategy. This high-visibility role offers global exposure and the opportunity to design support models...Hourly payTemporary workWork at officeRemote work3 days per week$189.5k - $235k
Vacancy Name Director, Regulatory Affairs-Global Regulatory Lead Vacancy No VN723 Employment... ...scientific and tactical strategy development, IND... ...pioneering, commercial-stage T cell receptor biotechnology company... ...first-in-class biological therapies to patients, we have...Full timeWork at officeLocal areaRemote workWorldwideNight shift- ...AstraZeneca in Gaithersburg, MD seeks a Director, Patient Services Strategy for US Cell & Gene Therapy to build the patient services approach from concept through execution. This role collaborates across Brand Marketing, Market Access, Commercial Operations, Medical,...
- Role: The Director of Regulatory CMC for Cell Therapy oversees management of multiple development and lifecycle projects, representing GRS-CMC... ...Responsibilities include developing and communicating global regulatory strategies, preparing and reviewing CMC submissions,...
$145k - $213k
...Role At AstraZeneca Cell Therapy, we are building the... ...patient-centered, and globally scalable supply chain... ...across borders. The Director, Cell Therapy Trade Compliance... ..., Quality, Regulatory, Finance, Procurement... ...compliance operations strategy and operating model for...Hourly payTemporary workWork at officeFlexible hours3 days per week- ...AstraZeneca seeks a Regulatory Affairs Director to shape US regulatory strategy for oncology therapies, accelerating innovation and patient access. You will lead regional regulatory... ..., approval and lifecycle management in a global matrix environment. You will drive major...
$208.06k - $262.15k
...to fairness, integrity, and global collaboration. This belief is... ...implementing a global growth strategy for USP’sexternally fundedregulatory... ...scientific integrity, regulatory excellence, and evidence-based... ...the followingdirect reports:Director / Sr Manager, International regulatory...Full timeWork experience placementWork at officeWorldwide$219.95k - $266.52k
...who do it. The GRS-CMC Director is responsible for... ...strategic direction based on global regulatory guidelines and experience... ...requirements for advanced therapies and/or and cell therapy during development... ...effective global regulatory strategies in coordination with...Hourly payFull timeSummer workLive inLocal areaRemote workFlexible hoursShift work$115.92k
...Associate Director leading trade compliance operations for AstraZeneca's cell therapy supply chain network. Responsible for building scalable import/export and Free Trade... ...to support patient-centered therapies across global sites. Responsibilities Lead trade...$210.86k - $242.79k
...AstraZeneca seeks a Director to develop and execute the US patient services strategy for its cell and gene therapy portfolio. This role involves designing support models across complex treatment pathways, leading cross-functional teams, and advancing launch readiness...- AstraZeneca in Gaithersburg is seeking a Global Regulatory Affairs Director to provide strategic regulatory leadership across development, commercialization... .... You will apply global regulatory trends to shape strategies and influence authorities to improve outcomes. The role...
- ...AstraZeneca by leading strategy for our industry-... ...deliver cutting‑edge therapies that improve patient outcomes... .... As Executive Director, Oncology Business Unit... ...with Oncology R&D and global franchise partners.... ...Thorough understanding of regulatory and pricing dynamics in...Hourly payTemporary work
$166.65k - $277.75k
...Regulatory DirectorEnsure the development of appropriate regulatory strategies and their execution for assigned Vaccines asset(s) consistent... ...as a component of an overall global regulatory approach and... ...according to plans. The Regulatory Director may be the single point of...Temporary workLocal area$201.58k - $237.21k
...Director, Regulatory Affairs with CMC FocusThe Director, Regulatory Affairs... ...for Miltenyi Biomedicine's cell therapy programs in the US, Canada,... ...develop and implement regulatory strategies that support clinical... ...Regulatory CMC in meetings with global health authorities,...Work at office- ...CRB is seeking a Director, Oligo & Peptide Market Segment Leader to drive long-term global growth in the life sciences facility sector. You will lead a cross-functional team, shape strategy, and expand CRB’s presence in oligo and peptides markets worldwide. This role...Worldwide
$196.7k - $353.4k
The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters... ...disease vaccines as unprecedented new drug modality globally. The Sr. Director will be a strategic leader within Global...Permanent employmentFull timeWork at officeWork from home$212.99k - $319.44k
...Job Title: Senior Director Global Regulatory, Digital Location: Gaithersburg At AstraZeneca, we put patients first and strive to meet their... ...to Role: The Senior Director, Global Regulatory Digital Strategy is accountable for the development and implementation of a...Hourly payTemporary workWork at officeWorldwide3 days per week- ...pushing the boundaries of cancer therapy and Autoimmune disease to... ...Description:Role SummaryThe Director, Regulatory Affairs Advertising,... ...internal subject matter expert on global labelling, Advertising & Promotion... ...and Medical Communication Strategy Development: Develop and...Local areaFlexible hours
- Autolus Inc. is seeking a Director of Regulatory Affairs Advertising, Promotion & Labelling to lead global labeling and promotion strategy, ensuring compliance across the US/UK/EU. You will partner with Commercial, Medical, Legal, and Compliance teams to deliver compliant...
- Overview Manager, Regulatory Affairs US Remote Emmes Group: Building... ...leading capabilities in cell and gene therapy, vaccines and infectious... ...Regulatory Affairs is a regulatory strategy leader who advises both... ...and apply relevant global and regional regulatory requirements...Casual workLocal areaRemote workWork from homeFlexible hours
- Role Senior leader responsible for global Market Access, HTA, pricing, and evidence generation strategies for oncology products, focusing on KIMMTRAK (tebentafusp). Responsibilities develop and lead RWE and HEOR strategies across 40+ countries collaborate with Commercial...
- The Director will be a core strategic leader and member of the global Market Access team responsible for shaping and executing... ...pricing, and evidence generation strategies, encompassing Real World... ...Medical, Clinical Development, Regulatory, Biostats and Project Management...Local areaFlexible hours
$160k - $218k
...Maryland / RemoteOperations - Regulatory /Full Time /HybridSince our founding... ...what’s possible in gene therapy. Today, we are advancing a pipeline... .... The opportunityAs Associate Director, Regulatory Affairs, you'll lead global regulatory strategy for a therapeutic area from...Full timeWork experience placementSummer workLocal area$186.23k - $279.35k
...Global Regulatory Affairs DirectorAt AstraZeneca, we put patients first and strive to meet their... ...future regulatory requirements and strategies. Influences Regulatory authorities through... ...for product developments regional therapy area· Represents AZRA on relevant external...Hourly payTemporary workWork at officeLocal areaWorldwide3 days per week$147.02k - $220.53k
...The Oncology therapy area at AstraZeneca is unparalleled. We have built and strategically... ...in creating and defining contract strategies that include financial analytics and platforms... ...and in-line products. The Associate Director of Contract Strategy may partner with customer...Contract workTemporary workShift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Regulatory Strategy - Cell Therapy (Global). Be the first to apply!
- regulatory manager Gaithersburg, MD
- regulatory affairs manager pharmaceutical Gaithersburg, MD
- director global regulatory affairs Gaithersburg, MD
- regulatory & compliance manager Gaithersburg, MD
- compliance manager Gaithersburg, MD
- regulatory affairs director Gaithersburg, MD
- compliance director Gaithersburg, MD
- sr. manager regulatory compliance Gaithersburg, MD
- senior regulatory manager Gaithersburg, MD
- manager regulatory affairs Gaithersburg, MD




