Global Regulatory Strategy Director - Cell Therapy
AstraZeneca
AstraZeneca in Gaithersburg, MD, seeks a Director of Regulatory Affairs Strategy for Cell Therapy. You will shape global regulatory pathways for advanced therapies, coordinating with senior leaders and global teams to align strategy with patient needs and business goals. You will lead regulatory design, filings, and interactions with Health Authorities, ensuring timely, well-supported submissions and robust post‑approval planning across oncology and immune-mediated indications. #J-18808-Ljbffr AstraZeneca
- AstraZeneca seeks a Senior Director of Regulatory Affairs Strategy for Cell Therapy to spearhead global regulatory vision across multiple indications. You will guide programs from discovery to licensure, aligning with clinical, CMC, safety and commercial teams to accelerate...Suggested
- 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...Suggested
$218.06k - $327.09k
Job Title Senior Director, Regulatory Affairs Strategy - Cell Therapy Locations Gaithersburg, MD Boston, MA South San Francisco, CA Santa Monica, CA Introduction to role Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough...SuggestedHourly payTemporary workFlexible hours$186.23k - $279.35k
Director, Regulatory Affairs Strategy - Cell Therapy Introduction to role Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care for patients? In this Director role, you will shape the regulatory path for programs that span...SuggestedHourly payTemporary workLocal areaFlexible hours$276.13k - $414.19k
Executive Director, Regulatory Affairs Strategy - Cell & Gene Therapy Location: Gaithersburg, MD Introduction to Role Are you ready to set the global regulatory direction for first‑in‑class cell and gene therapies and turn science into approved medicines? Do you see yourself...SuggestedHourly payTemporary workFlexible hours- AstraZeneca in Gaithersburg, MD is seeking an Associate Director Global Quality Systems to own and improve quality processes and digital systems across the Cell Therapy enterprise, ensuring inspection readiness and compliance with cGMP, GxP, and ICH standards. You will...
- ...Maryland is seeking an Associate Director of Material Management to... ...on-time delivery for cell therapy materials. The ideal candidate... ...and a strong understanding of regulatory compliance in the pharmaceutical... ...process, collaborating with global teams, and developing...
$115.92k - $173.88k
Overview Associate Director, Cell Therapy Trade Compliance Operations Introduction to role: Are you... ...chain of custody while meeting strict regulatory expectations. Your leadership will ensure... ...for Senior Specialists supporting global trade compliance operations. Set priorities...Temporary workWork at officeImmediate start3 days per week- SeQure DX is searching for a Director of Product Management in Rockville,... ...developing and executing marketing strategies aligned with business objectives... ...have significant experience in global commercial strategy within cell and gene therapy or related markets, and a strong...
- Merck & Co. is hiring a Principal Scientist for Regulatory Affairs in Rockville, MD. This role focuses on developing global regulatory strategy for vaccine and infectious disease projects. The successful candidate will lead the Global Regulatory Team, coordinate cross-functional...
$186.23k - $279.35k
...about science and experienced within regulatory affairs and drug development? Do you... ...affairs to get involved in the global regulatory strategies and support the research, development... ...business. The Regulatory Affairs Director (RAD) provides strategic and operational...Hourly payTemporary workWorldwide3 days per week- AstraZeneca seeks a senior brand leader to drive global COPD strategy and launch excellence. You will partner with cross‑functional teams to translate priorities into launch plans, measurements, and accountable ownership across global and country teams. You will shape...
- A leading construction brand is seeking a Director, Legal to serve as the sole in-house legal advisor. This role involves overseeing legal... ...while supporting business growth. Remote work with required global travel is part of the position. #J-18808-Ljbffr LATICRETE InternationalRemote work
$124.5k - $236.5k
Senior Manager, Regulatory Affairs US Advertising and Promotion... ...Salary Min: 124500 Therapy Area: Immunology... ...Max: 236500 Workday Global Grade: 19 Compensation... ...needed. Supports the Director in efforts to influence... ...guides implementation strategies for promotional activities...Full timeWork at officeRemote work- The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities... ...contributes to regulatory submission strategy, identifying submission risks and... ...and documentation requirements to GRET (Global Regulatory Execution Team), GRST (Global...
$153k - $229k
AstraZeneca in Rockville, MD seeks a Director - Digital Business Partner & AI Strategy Lead to spearhead the digital transformation in Cell Therapy Technical Operations. The ideal candidate will lead strategic initiatives using advanced digital platforms and AI to enhance...- ...AstraZeneca by leading strategy for our industry-... ...deliver cutting‑edge therapies that improve patient outcomes... ...cancer. As Executive Director, Oncology Business... ...with Oncology R&D and global franchise partners. Engage... ...understanding of regulatory and pricing dynamics in...Hourly payTemporary work
- QIAGEN in the United States seeks a senior Global Regulatory Affairs leader to define and execute worldwide regulatory strategy for the IVD and Life Sciences portfolio. You will partner with executive leadership, regulators, and cross‑functional teams to ensure regulatory...Worldwide
- ...using our innovative manufacturing approach to cell and gene therapies. We are seeking a global Executive Director , Regulatory Affairs (level determined by candidate... ...Affairs provides regulatory leadership and strategy on cross functional sub teams and advises on...
- ATCC Biotechnology seeks a Senior Director of Human Resources to shape the future of science and global health. The role emphasizes strategic HR alignment, overseeing... ...and government contracting, focusing on HR strategy, change management, and workforce planning. Comprehensive...
- ...Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities, working with cross... ...requirements and demonstrated ability to influence the global internal/external regulatory environment. Experience...Work at officeLocal areaRemote workWorldwide
- ...located in Gaithersburg, Maryland, is seeking a Senior Director of Human Resources. This role leads HR strategy, oversees all HR functions, and collaborates... ...nonprofit organization dedicated to supporting the global scientific community, offering competitive salaries...
$250k - $300k
...our entrepreneurial roots to our current global presence, we’ve grown into a force for positive... ...is a senior global leadership role in Regulatory Affairs responsible for defining and executing the worldwide regulatory strategy for QIAGEN’s IVD (In Vitro Diagnostics) and...Local areaWorldwide- ...Accountabilities: Vision and Strategy: Define a multi-year AI/digital... ..., and an investment roadmap. Global Standards and Transformation:... ...privacy, security, and regulatory alignment across markets. Use... ...advancing pipeline across multiple therapy areas and deep partnerships...Hourly payContract workTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week
- AECOM is hiring a Program Management Director to lead large-scale infrastructure programs in a hybrid work environment (US locations including... ...strategic direction, risk management, and collaboration with global business lines to identify opportunities and deliver value....For contractorsFor subcontractor
- BioSpace is seeking a Program Manager in Rockville, Maryland, to manage projects within the Global Biologics Department. This role involves developing project timelines, managing deliverables, and ensuring alignment with strategic goals across various therapeutic areas...
$87.76k - $108.4k
...Manager to oversee internal projects related to biological standards. The successful candidate will manage workplans, collaborate with global teams, and ensure effective project delivery. USP promotes a culture of inclusiveness, valuing diverse expertise in advancing...$157.5k - $262.5k
...development of and translating program strategies into cross-functional plans... ...pre‑clinical, manufacturing, regulatory, clinical, safety, data... ...and key internal processes (therapy area strategies,... ...in immunology, biochemistry, cell biology or related discipline...Temporary workWork experience placement- BioSpace is seeking a Project Director to lead a multi-country program addressing the impact... ...high-quality delivery aligned with global health priorities. The successful candidate... ...in pharmaceutical stability and regulatory compliance, overseeing projects across diverse...
- Auberge Collection in Bethesda, MD is seeking a Benefits Manager to oversee and enhance the administration of U.S. benefits programs, ensuring compliance and strategic oversight. This role involves managing vendor partnerships and collaborating with internal teams to improve...
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