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
Vacancy posted 13 hours ago
Similar jobs that could be interesting for youBased on the Global CMC Reg Director - Cell & Gene Therapy in Gaithersburg, MD vacancy
- ...Associate Director, Cell Therapy Trade Compliance Operations Introduction to role: Are you ready to build a world-class trade compliance... ...direct people leadership for Senior Specialists supporting global trade compliance operations. Set priorities, clarify roles and...SuggestedHourly payTemporary workWork at officeImmediate startFlexible hours3 days per week
$148k - $222k
...About the role, the Director, Operational Excellence (OE) leads the network-wide OE agenda for AstraZeneca's autologous Cell Therapy. You will establish basic conditions and eliminate waste across the vein-to-vein value stream. You will operate in a matrix with site-based...SuggestedTemporary work- ...to deliver life-changing medicines. Our global Safety Sciencesorganizationdelivers innovative... ...we bring medicines forward. Advanced Cell Models (ACM), such as organoids and Microphysiological... ...strategy, we are looking to recruit a Director, Advanced Cell Model External Engagement,...SuggestedHourly payTemporary work
$145k - $175k
...biopharmaceutical company pioneering cell and gene therapy solutions to transform the treatment of... ...for patients worldwide. As Associate Director, Regulatory Affairs , you will play a... ...functional teams to navigate the FDA and global regulatory landscape. Position...SuggestedFull timeWork at officeLocal areaImmediate startWorldwideMonday to FridayFlexible hoursAfternoon shiftKolon TissueGene, Inc.
Rockville, MD3 days ago$136.5k - $227.5k
...Vacancy Name Associate Director, TMF Operations and Clinical... ...appropriate. • Develop and oversee global TMF-related standards,... ...pioneering, commercial-stage T cell receptor biotechnology... ...delivering first-in-class biological therapies to patients, we have...SuggestedFull timeContract workImmunocore Limited
Gaithersburg, MD13 hours ago- ...biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable... ...products and to further our efforts we are seeking a Director, Medical Affairs will be instrumental in supporting the...
Precigen
Germantown, MD2 days ago - Israelvcforum is looking for a Director of Medical Affairs in Germantown, Maryland, to define strategies and support the company's first commercial launch. This role involves collaborating with key opinion leaders and healthcare practitioners, ensuring accuracy in scientific...
- AstraZeneca GmbH is seeking a Director for Advanced Cell Model External Engagement at our Gaithersburg, MD site. This role is integral to the Advanced Cell Models Team, focusing on strategic planning and stakeholder collaboration to validate novel drug development methods...
- Senior/Executive Director of Human Resources Precigen is a dedicated commercial, discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases...Local area
- ...innovation, improving care, and addressing unmet patient needs globally. The team is responsible for shaping commercial strategy, supporting... ...areas. We are seeking a Global Commercial Associate Director to help drive franchise performance, support future launch readiness...Hourly payTemporary work
AstraZeneca
Gaithersburg, MD2 days ago - ...Global Marketing Associate Director, Breast Cancer At AstraZeneca, we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. We're focused on the potential of science to...Hourly payTemporary work
AstraZeneca
Gaithersburg, MD1 day ago - ...biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases... ...AUR200, a dual inhibitor of B cell activating factor (BAFF) and a proliferation... ...Job Overview The Medical Director is a therapeutic and disease area expert...
Aurinia
Rockville, MD3 days ago $136.5k - $227.5k
Key Responsibilities Lead the day-to‑day execution of global safety operations, ensuring all ICSR (clinical and post‑marketing) are processed, quality‑checked, and submitted within strict regulatory timelines. Act as the primary point of escalation for complex case‑processing...Contract work$124.07k - $186.1k
Job Title: Associate Director Site Supply Chain Join AstraZeneca’s Cell Therapy Operations as the Associate Director, Site Supply Chain, leading end-to-end planning... ...with Manufacturing, Quality, Operations, and Global Supply Chain, you will drive the S&O&E cadence, optimize...Hourly payTemporary work- AstraZeneca GmbH is looking for a Global Commercial Associate Director to drive franchise performance in Gaithersburg, Maryland. This role will be key in translating scientific and market insights into commercial strategies across multiple solid tumor indications. The...
$169.32k - $253.98k
AstraZeneca is seeking a Director for the Cybersecurity Operations Center in Gaithersburg, Maryland. This senior role focuses on leading incident response across cloud and on-premises environments, defining incident categories, and ensuring comprehensive cybersecurity...- ...validation protocols Own and lead analytical work packages within global technical operations independently Participate in technical... .../MAA) Proficiency in project management within cross-functional CMC teams and external stakeholder environments Exceptional communication...
$125.06k - $187.59k
Are you ready to orchestrate complex global medical plans that speed life-changing cancer medicines to patients? Do you thrive at the... ...Global Medical Affairs Leader and reporting into a Tumor Portfolio Director. You will connect science, evidence and medical strategy to...Hourly payTemporary workWork at officeLocal areaFlexible hours3 days per week$194.57k - $291.86k
Job Title Global Analytics & Insights Associate Director, Oncology (Lung) Location: Gaithersburg, MD US Introduction to role Global Analytics & Insights (GA&I) mission is to improve the quality of the decisions taken on our oncology assets through the creation and delivery...Hourly payTemporary work- ...unexpected teams together. The Oncology therapy area at AstraZeneca is unparalleled. We... ...life changing medicine. Associate Director, Oncology Policy Strategy As the... ...Diseases Business Unit, Market Access team, Global teams, and others. In this role,...Hourly payTemporary workWork at office3 days per week
- ...Rehab Director Opportunity 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....Full timeMonday to Friday
ProVenture, LLC
Rockville, MD13 hours ago $162.54k - $243.8k
...About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing... ...to being a Great Place to Work. About the Role The Director of Cyber Threat Intelligence will lead a highly technical CTI function...Temporary workWork at officeFlexible hours3 days per weekAstraZeneca
Gaithersburg, MD4 days ago- ...innovation, improving care, and addressing unmet patient needs globally. The team is responsible for shaping commercial strategy, supporting... ...areas. We are seeking a Global Commercial Associate Director to help drive franchise performance, support future launch readiness...Hourly payTemporary work
$218.33k - $327.49k
...the combined efforts of all our people. Within the AstraZeneca Cell Therapy Enterprise, our ambition is to realize the full potential of... ...collaboration with AstraZeneca’s Therapeutic Area Units. The Senior Director, Competitive Insights and Analytics team sits at the heart of...Hourly payTemporary 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$148.37k - $185.46k
...AI Transformation Office (EAI‑T), you will support the Senior Director, Culture & Capability by designing and delivering EAI capability... ...engagement strategy within their respective teams. Partner with Global Corporate Affairs to create and disseminate Enterprise‑wide AI...Temporary workWork at office$143.62k - $215.43k
Job Title: Director Occupational Toxicology Introduction to role Are you ready to lead the charge in occupational toxicology within Global Safety, Health and Environment (SHE)? As the Director of Occupational Toxicology, you will develop strategies and provide expert advice...Hourly payTemporary work- ...Summary Altimmune is seeking an Associate Director, R&D Finance, to serve as the primary... ...role will be the point of contact for the global CRO, the Controller, and the VP Head of Global... ...Clinical Operations, Program Management, CMC, and Accounting to ensure accurate...Contract work
- ...DIRECTOR OF REHABILITATION (PT, PTA, OT, COTA, SLP) MUST BE A GRADUATE OF AN ACCREDITED PROGRAM AND LICENSED IN THE STATE TO PRACTICE. Duties/Responsibilities: Schedules treatment daily for PTs, PTAs, OTs, OTAs and SLPs. Monitors productivity. Meets with...
Vita Healthcare Group
Rockville, MD2 days ago $137k - $235.75k
...best talent for the role of Associate Director, Oncology Epidemiology . We have a preference... ...on specific diseases, conditions, or therapies particularly relating to Oncology... ...is preferred. Experience working in a global environment is preferred. Johnson & Johnson...Full timeTemporary workLocal areaRemote workJohnson & Johnson
Gaithersburg, MD2 days ago
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!
Related searches
- director lease administration Gaithersburg, MD
- director of benefits Gaithersburg, MD
- nonprofit director Gaithersburg, MD
- director of video production Gaithersburg, MD
- director biotech Gaithersburg, MD
- director m&a integration Gaithersburg, MD
- director of innovation Gaithersburg, MD
- director workforce management Gaithersburg, MD
- non profit director Gaithersburg, MD
- director of mental health Gaithersburg, MD