Senior Global Regulatory Strategy Lead, Biologics
REGENXBIO Inc.
REGENXBIO Inc. in Rockville, MD, seeks an Associate Director, Regulatory Affairs to lead global regulatory strategy from early development through marketing authorization, translating complex requirements into clear paths forward and coordinating across functions. You will drive submission activities, prepare FDA/EMA documentation, and guide labeling and promotional materials while shaping ex-US strategies with regional experts. Travel up to 15% may be required. #J-18808-Ljbffr REGENXBIO Inc.
- Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions, and... .... The successful candidate will bring a strong biologics background, strategic leadership, and the ability to...RegulatoryRemote job
- ...a week on siteReporting to the Global Medical Head, the Senior Global Medical Affairs Lead, Cardiovascular & Renal is a highly... ...and leads bold medical strategies within the CVRM (Cardiovascular... ...of healthcare system pathways, regulatory landscapes, market access, and...SeniorRegulatoryHourly payFull timeTemporary workWorldwide3 days per week
- ...AstraZeneca seeks a Senior Global Medical Affairs Lead for its Cardiovascular & Renal therapy area. This executive role drives medical strategy, evidence generation, and healthcare transformation... ...in healthcare system pathways, regulatory landscapes, and external...SeniorRegulatory
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$135.62k - $203.44k
...Gaithersburg, MarylandReports to: Senior Director, Global Regulatory Strategy About Alexion For over 30 years, Alexion... ...living with rare diseases. We lead with breakthrough science, deep disease... ...subject areas to turn complex biology into transformative medicines, learning...SeniorRegulatoryFull timeTemporary workWork at office- ...AstraZeneca plc in Gaithersburg, MD is hiring a Senior Director, Global Commercial for panKRAS to lead the global commercial strategy for a multi-target KRAS inhibitor across GI... ...Clinical Development, Medical Affairs, Regulatory, Pricing & Market Access, Analytics,...Regulatory
$208.06k - $262.15k
...with the world’s leading health and science... ...fairness, integrity, and global collaboration.... ...a global growth strategy for USP’sexternally... ...integrity, regulatory excellence, and evidence... ...pharmaceuticals and/or biologics(GxPs).Experience... ...programs Senior Pharmacovigilance...SeniorRegulatoryFull timeWork experience placementWork at officeWorldwide$185k - $278k
...monitoring, and the unique biological risks inherent in... ...~ Collaborate with Global Real Estate and Engineering... ...input to and/or lead engineering studies to... ...and develop mitigation strategies that inform capital prioritization... ...and current regulatory expectations for cell...SeniorRegulatoryTemporary work$189.5k - $235k
Vacancy Name Director, Regulatory Affairs-Global Regulatory Lead Vacancy No VN723 Employment Type Full Time Location... ...scientific and tactical strategy development, IND development/submission... ...will have experience gained in biologics and the preparation of late-stage...RegulatoryFull timeWork at officeLocal areaRemote workWorldwideNight shift- ...We are focused on leading a revolution in oncology... ...the lifecycle.The Senior Director of Pathology Diagnostics, Global Oncology... ...global scientific strategy related to pathologic... ...(e.g., Molecular Biology, Pathology), with... ...payersFamiliarity with global regulatory organizations,...SeniorRegulatoryHourly payFull timeTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week
- Green Key Resources is seeking a highly technical Regulatory Affairs Manager / Senior Manager in Gaithersburg, MD for a 100% hands-on... ...and coordinate CMC submissions, manage regulatory strategy, and collaborate with global teams and CMOs/CROs. The ideal candidate has a Master...SeniorRegulatory
- US Pharmacopeia is looking for a Senior Technical Director for Global Manufacturing Programs to provide strategic technical leadership for key global... ...externally. The successful candidate will influence program strategy and manage complex stakeholder environments effectively,...Senior
- AstraZeneca in Gaithersburg, MD is seeking a Medical Lead for Breast Cancer in US Oncology Medical Affairs to guide medical strategy and lead the Core Medical Team. You will collaborate across global and US functions to translate scientific priorities into measurable outcomes...Senior
- ...Senior Director leading global regulatory digital transformation strategy at AstraZeneca. Accountable for developing and implementing digital and data strategies aligned with regulatory business priorities, managing cross-functional teams, and establishing governance frameworks...SeniorRegulatory
- AstraZeneca is seeking a Global Clinical Program Lead in Late Respiratory and Immunology Clinical Development... ...a cross‑functional team, and shape strategy to deliver trials and publications.... ..., and deep knowledge of GCP and regulatory standards. Office-based with phased...SeniorRegulatoryWork at office
$182.5k - $208.3k
Senior Business Manager, Velocity Black Strategy & Analytics LeadVelocity Black, a Capital One company, is a luxury lifestyle... ..., you will act as the strategic lead for our Velocity Black business,... ...the face of shifting consumer and regulatory behaviorBusiness ownership: Have...SeniorRegulatoryFull timeTemporary workPart timeLocal areaShift work- ...AstraZeneca seeks a Senior Medical Director to lead clinical development programs in hematology oncology. This role oversees early... ...phase trial design, execution, safety monitoring, and regulatory strategy within a global, cross-functional team environment....SeniorRegulatory
$200.81k - $286.16k
...vital role in increasing global access to high-quality... ...scientific integrity, regulatory excellence, and... ...work environments.The Senior Technical Director, Global... ...with approved program strategies and donor objectives.Oversee... ...stakeholders, leading or contributing to technical...SeniorRegulatoryFull timeWork at officeWorldwide$247.79k - $371.68k
...AstraZeneca seeks a Senior Director to lead global scientific strategy for pathology diagnostics in oncology, focusing on digital and computational pathology... ...or CRO settings (preferred) ~ Knowledge of global regulatory frameworks, GCP, and companion diagnostic...SeniorRegulatory- Description Senior Technical Director, Global Manufacturing Programs, serves as a strategic... ...and donor-driven strategies into executable program plans... ...across manufacturing, regulatory, market access, and... ...organization externally, leading or contributing to engagements...RegulatoryFull time
- ...AstraZeneca seeks a Senior Director to lead APOLLO, a global oncology real-world data platform supporting evidence... .... The role combines scientific strategy, partner ecosystem development,... ...assess potential data partners for regulatory and publication-grade suitability...SeniorRegulatory
$182.16k - $246.88k
...collaborates with the world’s leading health and science experts... ...fairness, integrity, and global collaboration. This belief... ...environment.Brief Job Overview The Senior Enterprise Strategy Director is a highly... ...prioritizes scientific integrity, regulatory excellence, and evidence-...SeniorRegulatoryFull timeWork experience placementWork at officeWorldwide$288.06k
Senior Global Development Medical DirectorAstraZeneca is seeking a Senior... ...the Global Clinical Head, regulatory agencies, external medical... ...expertise to pricing and value strategies.Key responsibilitiesMedical... ...of clinical studies.Lead study design concepts and establish...SeniorRegulatoryFull timeTemporary workWork at officeWorldwide3 days per week- ...operational glue for program execution and alliances. The role requires identifying strategic opportunities, driving internal product strategy across Research, Clinical Development, and Regulatory, and managing relationships with external partners. #J-18808-Ljbffr MacroGenicsSeniorRegulatory
- ...'t sponsor H1B. Arcetyp LLC is looking for a Senior DoD Regulatory Affairs SME – Drugs, Biologics & Medical Devices . This position is onsite and located... ...solutions. Develop and review regulatory strategies and submission plans. Prepare/review INDs, NDAs,...SeniorRegulatoryFull timeH1bRemote work
$93.1k - $232.8k
...treatments to patients faster.Drive global clinical trials from first... ...final patient visit—own the strategy, accelerate delivery, and... ...point of contact for clients, lead cross-functional teams, and ensure... ...compliance with ICH-GCP, regulatory requirements, and study...SeniorRegulatoryFull timeContract workPart timeWork at officeImmediate startWorldwide- ...Product Marketing to shape and execute brand strategy across HCP, payer, caregiver, and field... ...a fast-paced biotech environment. You will lead cross-functional collaboration with Commercial, Medical, Market Access, Regulatory, and R&D to align messaging, generate insights...SeniorRegulatory
$200.18k - $286.16k
...collaborates with the world’s leading health and science... ..., integrity, and global collaboration. This belief... ...The Global GotoMarket Senior Director is... ...Global SCD VP to align strategy, governance, and execution... ...scientific integrity, regulatory excellence, and evidence...SeniorRegulatoryFull timeWork at officeLocal areaWorldwide- ...Therapeutic Area Units. The Global Analytics & Insights... ...analytics. The Senior Director, Global Analytics... ...Head, Cell Therapy, and lead a program of insights and... ...markets to shape portfolio strategy, asset development... ...Commercial, R&D, Medical, Regulatory, Market Access, and...SeniorRegulatory
- ...opportunity to work in the Global Cell Therapy Franchise as the Senior Director, Global... ...drive the global commercial strategy for the cell therapy portfolio... ...Medical, Market Access, Regulatory, Manufacturing, Supply,... ...advantage. Experience leading multiple indications...SeniorRegulatory
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