Global Regulatory Strategy Leader, Cell & Gene Therapy
$276.13k - $414.19kAstraZeneca
AstraZeneca is seeking an Executive Director for Regulatory Affairs Strategy, specializing in Cell & Gene Therapy, based in Gaithersburg, MD. This role involves setting global regulatory strategy for advanced therapies, ensuring timely approvals, and engaging with health authorities. The ideal candidate has a strong background in regulatory affairs and significant experience with cell and gene therapies. The competitive salary ranges from $276,127 to $414,190 annually, with comprehensive benefits including health coverage, retirement plans, and incentive bonuses. This position advocates for inclusivity and welcomes diverse applicants. #J-18808-Ljbffr 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...Regulatory
- 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...Regulatory
- 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... ...-functional teams, partner with senior leaders, and manage Health Authority...Regulatory
- ...focused on clinical trial programs for gene and cell therapies. You will oversee clinical trials... ...ensuring they meet timelines, budgets, and regulatory guidelines. The role requires a PhD,... ...the chance to implement corporate strategy and collaborate across functions to ensure...Regulatory
- ...Within the AstraZeneca Cell Therapy Unit (CTU), our ambition is... ...The Executive Director, Global Product Leader (GPL – Solid Tumor Franchise... ...registrational investment strategies. This individual will be accountable... ...development, coupled with regulatory knowledge · Strong...RegulatoryHourly payTemporary work
$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... ...indications and modalities. As a senior leader, you will build capability,...RegulatoryHourly payTemporary workFlexible hours$217k - $325.49k
...Gaithersburg, Maryland is looking for a senior leader to define and execute the Global MSAT function strategy in cell therapy. The candidate will play a crucial role in... ...therapy manufacturing and ensuring compliance with regulatory submissions. Applicants should have 12+ years...Regulatory$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...RegulatoryHourly payTemporary workFlexible hours$96.2k - $144.3k
...senior process engineer for our cell therapy Global Manufacturing Science and... ...of process validation strategy, leading implementation of continuous... ...to validation and regulatory deliverables to enable commercialization... ...in a fast‑paced cell & gene therapy field. The annual...RegulatoryTemporary work$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... ...program decision‑making. Partnering with senior leaders and global teams, you will lead strategy...RegulatoryHourly payTemporary workLocal areaFlexible hours- ...Senior QA Auditor to drive risk-based quality assurance across cell therapy manufacturing sites, suppliers, and contractors. Based in... ...The Netherlands, the role requires deep cGMP expertise and global regulatory awareness. The ideal candidate will lead complex audits,...RegulatoryFor contractors
$217k - $325.49k
...Technology in Gaithersburg, Maryland. This role involves leading global cell therapy manufacturing efforts, overseeing technical processes from... ..., strong leadership skills, and a proven track record in regulatory submissions. A competitive salary range of $216,996 to $325...Regulatory$116k - $173k
...winning team supporting Cell Therapy in one of the world’s... ...AstraZeneca is a global, science-led, patient-... ...deployment of global category strategies and initiatives,... ...initiatives for LVV, Plasmids, Gene Editing, and Drug... ...'s biotech ecosystem, regulatory environment, and...RegulatoryTemporary work$96.2k - $144.3k
...experienced Senior Process Engineer to join our Global Manufacturing Science and Technology (MS&T)... ...Gaithersburg, MD. The role involves overseeing cell therapy manufacturing processes, ensuring compliance with regulatory standards, and leading technology transfers. Ideal...Regulatory- ...processes ensuring on-time delivery for cell therapy materials. The ideal candidate will... ...planning and a strong understanding of regulatory compliance in the pharmaceutical industry... ...materials planning process, collaborating with global teams, and developing process...Regulatory
$217k - $325.49k
Team Leadership & Strategy Define and execute the Global MSAT function strategy aligned with Cell Therapy Technical Operations... ...rigor and managing regulatory risks. Identify and... ...accountable MSAT leader for regulatory submissions... ...fast‑paced cell & gene therapy field....RegulatoryRemote work- ...Support & Inside Sales Representative – Cell and Gene Therapy CRO Services Location: Germantown... ...teams, including production, regulatory, and marketing, to ensure customer satisfaction... ...service offerings and marketing strategies. Industry Engagement: Attend customer...Regulatory
- ...biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare... ...Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. The TA Safety Manager supports adherence to Good...RegulatoryContract workFor contractorsCasual workLocal areaRemote workWork from homeFlexible hours
- ...This senior enterprise leader will set the vision... ...Accountabilities: Vision and Strategy: Define a multi-year... ...investment roadmap. Global Standards and... ...privacy, security, and regulatory alignment across markets... ...pipeline across multiple therapy areas and deep partnerships...RegulatoryHourly payContract workTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week
- ...Overview Ophthalmology Strategy and Medical Monitor... ...capabilities in cell and gene therapy, vaccines and infectious... ...assessment, regulatory and medical strategy,... ...ophthalmology Key Opinion Leaders (KOLs), site investigators... ...initiatives, both globally and in our local communities...RegulatoryContract workWork experience placementCasual workLocal areaRemote workWork from homeFlexible hours
- GlaxoSmithKline is looking for a highly experienced regulatory professional to lead Chemistry, Manufacturing and Controls (CMC) strategy. This role involves collaboration across development, manufacturing, and regulatory teams to ensure compliance and timely access to...Regulatory
- ...Job Title: Global Clinical Program Lead, Late Development... ...to steer late-stage cell therapy programs that can... ...trials that withstand regulatory scrutiny and deliver real... ...product and study strategy, set a clear vision, and... ...single-point accountable leader for the design,...RegulatoryHourly payTemporary workWork at officeLocal areaFlexible hours3 days per week
$216k - $324k
...Respiratory & Immunology (R&I) as a Global Product Leader (GPL) for an asset in... ...and deliver a successful strategy aligned to achieving the... ...on safety and efficacy for regulatory approval plus value for market... ...with specific and relevant therapy area expertise. Excellent...RegulatoryTemporary workWork at officeFlexible hours3 days per week- ...Operations in Germantown, Maryland, to drive clinical trial programs for gene and cell therapies. This leadership role requires 10+ years in pharma/biopharma clinical operations and strong knowledge of regulatory guidelines. The candidate will oversee execution, ensure...Regulatory
- 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...
- JobRx, Inc. is seeking a Regulatory Affairs Manager (RAM) based in Gaithersburg, Maryland, to lead the end-to-end planning and execution of regulatory deliverables. The RAM plays a key role in regulatory submissions, providing strategic insights and managing regulatory...Regulatory
$115k - $173k
...Director, External Operations, Cell Therapy - External Supply Management... ...Development, Quality, Regulatory, Procurement, and Finance to... ...partners following CMC Product Strategy. Oversee/coordinate change control... ...years of experience in cell and gene therapy including management...RegulatoryContract workTemporary work$154.7k - $290.3k
...Rockville, MD is seeking a Quality Assurance leader responsible for designing and... ...Management System to ensure compliance with regulatory standards in the pharmaceutical industry... ...driving continuous improvement across various global locations. The ideal candidate will...Regulatory- ...role focuses on developing and executing marketing strategies aligned with business objectives. Key... ...ideal candidate should have significant experience in global commercial strategy within cell and gene therapy or related markets, and a strong background in product...
$115.92k - $173.88k
Overview Associate Director, Cell Therapy Trade Compliance Operations Introduction to role:... ...chain of custody while meeting strict regulatory expectations. Your leadership will ensure... ...for Senior Specialists supporting global trade compliance operations. Set priorities...RegulatoryTemporary workWork at officeImmediate start3 days per week
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