Global Senior Regulatory Affairs Director — Strategy
Jobleads-US
AstraZeneca GmbH in the United States is seeking a Senior Regulatory Affairs Director to lead global regulatory strategy for complex products, driving rapid approvals and advantageous labeling.
You will chair the Global Regulatory Sub-team with regional input, manage regulatory milestones, and mentor RAD/ARAD staff across regions.
The role offers comprehensive benefits and a pathway to influence oncology programs and interactions with Health Authorities.
#J-18808-Ljbffr Jobleads-US$208.06k - $262.15k
...fairness, integrity, and global collaboration.... ...a global growth strategy for USP’... ...scientific integrity, regulatory excellence, and evidence... ...reports:Director / Sr Manager, International... ...laboratory programs Senior Pharmacovigilance... ...Category: Ext. Affairs, Regulatory, \& CommunicationsSchedule...SeniorFull timeWork experience placementWork at officeWorldwide- 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...Senior
$212.99k - $319.44k
...Job Title: Senior Director Global Regulatory, Digital Location: Gaithersburg At AstraZeneca, we put patients first and strive to meet their unmet... ...Role: The Senior Director, Global Regulatory Digital Strategy is accountable for the development and implementation of...SeniorHourly payTemporary workWork at officeWorldwide3 days per week- ...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... ...cross-functional teams, partner with senior leaders, and manage Health Authority...Suggested
- AstraZeneca in Gaithersburg is seeking a Global Regulatory Affairs Director to provide strategic regulatory leadership across development, commercialization... .... You will apply global regulatory trends to shape strategies and influence authorities to improve outcomes. The role...Suggested
- ...AstraZeneca plc in Gaithersburg is seeking a Senior Director for Global Regulatory Digital Strategy. You will lead the development and implementation of a comprehensive digital strategy across Regulatory, working with IT, AI units and external partners to ensure delivery...
$206.99k - $310.49k
...Boston, MA will also be considered Global Portfolio & Project Management (GPPM)... ...on average 3 days/week in office The Senior Director, OncologyGlobal Project Management is a... ...ClinicalCommercialLeaderstoestablishthe brand strategy and deliverthe approved project plans....SeniorTemporary workWork at officeFlexible hoursShift work3 days per week$200.81k - $286.16k
...vital role in increasing global access to high-quality medicines... ...scientific integrity, regulatory excellence, and evidence-... ...driven work environments.The Senior Technical Director, Global Manufacturing... ...alignment with approved program strategies and donor objectives....SeniorFull timeWork at officeWorldwide- ...Regulatory Affairs Manager / Senior Manager Gaithersburg, MD | Hybrid, onsite Tuesday through Thursday... ...documentation. Manage regulatory strategy, application maintenance, and commercial... ...authorities, international teams, and global CMOs/CROs. Requirements Master...SeniorFull timeSummer work
- ...research organization, seeks a Senior Director, Quality Assurance to lead the global QA program and support the VP of... ...Quality & Compliance. You will guide strategy, audits, and continuous... ...across worldwide trials, ensuring regulatory readiness and strong QMS governance...Worldwide
$235k - $335k
Rockville, MarylandCommercial - Global Program Management /Full Time /On-siteWho we areREGENXBIO... ...their communities.The opportunityAs a Senior Director, Global Program Development Lead (PDL),... ...you'll be doingLead overall program strategy, accountable for an integrated Program...SeniorFull timeWork experience placementSummer work- ...PharmaceuticalsSelling Points Lead impactful regulatory projects at a dynamic organization with global reach. Collaborate across... ...your expertise in regulatory affairs and CMC compliance.Job DescriptionOverviewLead regulatory strategy development and implementation for...Senior
- ...PharmaceuticalsSelling Points Lead impactful regulatory strategies in a dynamic pharmaceutical environment. Collaborate globally and grow professionally within a small,... ...DescriptionSenior Manager Regulatory Affairs OverviewThe Senior Manager Regulatory Affairs will lead...Senior
$120.05k - $171.07k
...to fairness, integrity, and global collaboration. This belief is... ...environment.Brief Job Overview The Senior Strategic Realization Program... ...the organization’s strategy into tangible results. This position... ...scientific integrity, regulatory excellence, and evidence-based...SeniorFull timeWork at officeWorldwide- Overview Senior Technical Director, Global Manufacturing Programs, serves as a strategic technical leader... ...organizational and donor-driven strategies into executable program plans, and... ...and coherence across manufacturing, regulatory, market access, and related program...SeniorFull time
- ...highly motivated and experienced Senior Manager/Manager, Regulatory Affairs(level based on candidate experience... ...for knowledge and application of global regulations governing pharmaceutical... ...and implementation of regulatory strategies for specific drug development programs...SeniorWork at office
- ...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...Senior
$182.16k - $246.88k
...commitment to fairness, integrity, and global collaboration. This belief is... ...environment.Brief Job Overview The Senior Enterprise Strategy Director is a highly visible role responsible... ...USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision...SeniorFull timeWork experience placementWork at officeWorldwide$135.62k - $203.44k
...Seaport, Boston or Gaithersburg, MarylandReports to: Senior Director, Global Regulatory Strategy About Alexion For over 30 years, Alexion has been dedicated... ...step. Role Overview:The Senior Manager, Regulatory Affairs US lead will be responsible for leading, planning,...SeniorFull timeTemporary workWork at office- ...ensures adherence to U.S. and global trade regulations while... ...to the United States. Drive Regulatory/ Operational Oversight: Oversee... ...quality, legal and Regulatory Affairs to ensure timely and compliant... ...operational excellence. Logistics Strategy & Operations:Own and execute...SeniorFull timeLocal area
- Role Senior Director of Regulatory Affairs overseeing global regulatory strategies for biologics development, with a focus on late-stage filings. Responsibilities lead IND, BLA, sBLA submissions develop regulatory scientific and tactical strategies liaise with FDA, EMA,...Senior
$196.7k - $353.4k
...:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs... ...unprecedented new drug modality globally. The Sr. Director will be a... ...and overall plans to Regulatory Affairs the Project Team and senior management, as relevant.May be responsible...SeniorPermanent employmentFull timeWork at officeWork from home$126.25k - $171.58k
...commitment to fairness, integrity, and global collaboration. This belief is... ...environment.Brief Job Overview The Senior International Regulatory Affairs Manager serves as a critical enabler... ...information, and to develop applicable strategies to align with expected outcomes....SeniorFull timeWork at officeWorldwide- ...AstraZeneca GmbH seeks a Strategy and Commercial Executive Director for Cell Therapy Strategy and Commercial (CTSC... ...for a therapeutic indication, lead global commercial initiatives, and align... ...access teams. You will influence senior leaders and drive launch readiness...
$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth... ...to role: Are you ready to steer global regulatory strategy for cell... ...program decision-making. Partnering with senior leaders and global teams, you will lead...Hourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- ...Axtria, Inc. is seeking a Senior Leader in its AI & Data Practice to drive transformative initiatives across cloud data management, analytics... ...delivery excellence, and provide strategic leadership for a global team of technology professionals. The role shapes Axtria's...Senior
- 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
$250k - $300k
...entrepreneurial roots to our current global presence, we've grown into a force... ... About the opportunity This is a senior global leadership role in Regulatory Affairs responsible for defining and executing the worldwide regulatory strategy for QIAGEN's IVD (In Vitro...Full timeLocal areaWorldwide- ...Job Description Job Description The Senior Manager, Global Promotional Regulatory Affairs is responsible for providing regulatory leadership and guidance... ...: Lead the promotional material and labeling strategy and activities for assigned products and therapeutic...Senior
- ...CRB is seeking a Director, Oligo & Peptide Market Segment Leader to drive long-term global growth in the life sciences facility sector... ...cross-functional team, shape strategy, and expand CRB’s presence in... ...leadership, and collaboration with senior leadership to pursue...Worldwide
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