Global CMC Reg Director - Cell & Gene Therapy
AstraZeneca GmbH
AstraZeneca GmbH is seeking a regulatory leader in Gaithersburg, MD, to oversee the global CMC strategy for cell and gene therapies. You will ensure the delivery of high-quality submissions and navigate complex health authority interactions. The ideal candidate will possess extensive regulatory experience, strong leadership skills, and a life sciences background. The role offers a competitive salary, benefits, and opportunities for professional growth. #J-18808-Ljbffr AstraZeneca GmbH
- Autolus Inc. in the U.S. seeks a Director, Payer Access Cell Therapy to lead market access across the Central/North East region. You will shape payer strategy, secure coverage, educate payers, and onboard treatment centers. This senior role requires 10+ years in payer relations...SuggestedRemote job
- AstraZeneca GmbH in Gaithersburg, MD seeks a Senior Administrative Assistant in the Cell Therapy Enterprise to manage meetings, travel, contracts and onboarding. You will support senior leaders including the COO and VP/SVP, coordinate interviews, and handle confidential...Suggested
$127.21k - $190.82k
...related projects for Neogene's portfolio of T-cell therapy programs. You will integrate the inputs... ...agendas, timelines, and agreement on the CMC development plan. Promote a culture of... ..., biologics manufacturing, and global operations. The annual base pay for this...SuggestedTemporary workWork at officeFlexible hours3 days per week- AstraZeneca GmbH in Gaithersburg, MD invites a Global Director of Forecasting for Infectious Disease to lead global demand forecasting across early-stage, late-stage, and in-market assets. You will partner with Finance, Market Access, Marketing, and Development teams to...Suggested
- ...finding a cure. What you'll do: ~ Lead the development and execution of the publication strategy and tactical plan for Oncology global clinical studies in humans from Phase Ib-IV, and non-clinical trial sources including health economics and outcomes research,...SuggestedHourly payTemporary workWork at office
$166.32k - $249.49k
...Director, Global Oncology Policy & Advocacy (Breast Cancer & Pan Tumour) Gaithersburg, USA Are you ready to shape the future of cancer care by turning scientific breakthroughs into system-wide change? Do you see policy as the lever that unlocks earlier diagnosis...Hourly payTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week$151.08k - $226.62k
...means working at the forefront of one of the most dynamic and meaningful areas in healthcare. We are looking for a Global Marketing Associate Director, HER2-ADC to join our Global Oncology Franchise Team in Gaithersburg, MD. This role will support our HER2-ADC portfolio...Hourly payTemporary workLocal area- Associate Director, Scientific Communications & Engagement At AstraZeneca our mission is to... ...world. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company... ...all that we do. We focus on three main therapy areas - Oncology, Cardiovascular & Metabolic...Worldwide
$110k - $125k
...and our people are impact‑obsessed. As a global agency, we provide a full suite of services... ...a talented and dynamic Associate Medical Director to join our growing Medical Affairs team.... ...impactful deliverables across multiple therapy areas. You’ll partner with cross‑functional...Work experience placementWork at officeLocal areaRemote workShift work- ...Jackson Therapy Partners is seeking an experienced Rehab Director for a full-time role with an area client where you'll recruit and train staff, develop therapy strategies, evaluate patient care, and coordinate rehabilitation services. Minimum Requirements Doctor...Full timeTemporary workRelocation packageMonday to Friday
$170k - $202.5k
## Job Details: Associate Director, Indication Marketing Lead (US)Full details of the job.|... ...IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose... ...on delivering first-in-class biological therapies to patients, we have developed a highly innovative...Full timeWork experience placement$90k - $100k
...Associate Product ManagerReady to shape the future of science and global health? A global nonprofit that provides trusted biological... ...product portfolios supporting ATCC's advanced model and primary cell business. Working in a hybrid environment (4 days/week onsite) in...$124.07k - $186.1k
...Introduction to role The Associate Director, Material Management will be responsible for the site planning of cell therapy materials used in the facility. You will oversee... ...process improvements - Collaborate with Global Material Planning and Purchasing for execution...Hourly payTemporary workWork at officeFlexible hours3 days per week- ...Bridgepoint-Associates, on behalf of a highly regarded nonprofit in the Washington, DC area, is seeking a Chief Operating Officer to lead global mission delivery and oversee a $75M operating budget. Reporting to the CEO, the COO will drive strategy, operational excellence,...
$146.3k - $234.1k
...As the Associate Director AS&T Lifecycle Management, you will be making a meaningful contribution... ...-stage and commercial projects across a global network • Responsible for the design... ...within projects cross-functionally with CMC team members and external partners •...Hourly pay$162.54k - $243.8k
About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing... ...committed to being a Great Place to Work. About the Role The Director of Cyber Threat Intelligence will lead a highly technical CTI function...Full timeTemporary workWork at officeFlexible hours3 days per week- The Director of Bacterial Vaccine Discovery in Early Infectious Disease leads efforts to... ...Partner with Early Vaccines and Immune Therapies Translational Sciences to develop and transfer... ...and Translational Medicine, and Global Project Teams to ensure cross-functional...Hourly payFull timeContract workTemporary work
- ...for an experienced, highly technical, and strategically minded Director to lead our cross-functional teams in building and deploying next... ...value for our commercial and medical functions across US and global markets. This role requires a unique blend of deep technical expertise...Hourly payFull timeTemporary workWork at officeFlexible hours3 days per week
- ...innovation and mentor teams in a dynamic, collaborative environment. Represent statistical expertise in global scientific forums.Job DescriptionStatistical Science Director - Late Oncology and Hematology OverviewThe Statistical Science Director leads biometrics teams in...
- ...groundbreaking research in bacterial vaccine development with a global impact. Collaborate with top-tier scientists and institutions... ...DescriptionDirector of Bacterial Vaccine Discovery OverviewThe Director of Bacterial Vaccine Discovery leads efforts in developing innovative...
- ...advancement.Job DescriptionStatistical Science Director OverviewAs a Statistical Science Director... ..., interpretation, and submissions.Lead global statistical strategies and direct project... ...strategy in internal governance and therapy area leadership teams.Investigate and implement...
- Senior Director, Cyber Exposure ManagementIntroduction to role:Are you ready to turn exposure data into decisive action that protects the... ...capacity against real-world risk and business pragmatism.Global coordination: Experience leading distributed teams across multiple...Full timeWork at officeWorldwideFlexible hours3 days per week
$164k - $247k
Main Duties and Responsibilities The Director, BPM Evidence Publications CVRM (Publications... ...execution of strategic publication plans for global clinical registration studies (R&D) and... ...combining deep publications strategy and therapy-area expertise with the responsible use...Hourly payFull timeTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week- ...and overseeing reproductive toxicology programmes that support global development and registration strategies across multiple therapeutic... ...’s Next? Are you ready to bring transformative science to B-cell leukemia patients? We’d love to hear from you. The annual base...Hourly payFull timeTemporary work
$188k - $282k
...profile and communicate these effectively within the team. Provide global leadership to others and direct project work delivered by... ...decision‑making at internal governance including review boards, therapy area leadership teams, and ESPC/LSPC. Mentor/coach and support...Hourly payTemporary workInterim roleWork at officeFlexible hours3 days per week$146.3k - $234.1k
...Job ID:11533 About the Role: As Associate Director, AS&T Projects & Strategy, you will play... ...network within the cross-functional late-stage CMC team, helping drive development programs... ...in intercultural, cross-functional, and global team environments. Excellent...Full time$169.22k - $253k
...Job Description Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating... ...products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka’s culture and...Temporary workInterim roleLocal areaRemote workWorldwideFlexible hours- ...The Centre of Oncology Data Excellence [CODE] is a team within Global Medical Evidence Generation organization that is passionate... ...research to support the Global and US Medical Affairs (GMA). Director, Scientific Writing reports to the Head, CODE and will be leading...Hourly payTemporary workFor contractorsWork at officeWorldwideFlexible hours
$150.2k - $225.3k
...and deepest Oncology pipelines in the business. The Associate Director, Oncology Outcomes Research is an individual contributor role and... ...of health outcomes and real-world strategies and studies on a global and US market level. This role is also responsible for working...Full timeTemporary work$138.75k - $231.25k
Associate Director Regulatory Affairs, OncologyAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2... ...together.This role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for...Full timeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global CMC Reg Director - Cell & Gene Therapy. Be the first to apply!
- director of loss prevention Gaithersburg, MD
- director talent acquisition Gaithersburg, MD
- infection control director Gaithersburg, MD
- director of inventory management Gaithersburg, MD
- director of benefits Gaithersburg, MD
- director biotech Gaithersburg, MD
- director of radiology Gaithersburg, MD
- director of fulfillment Gaithersburg, MD
- director of assessment Gaithersburg, MD
- director of community outreach Gaithersburg, MD


