Global GRA Audits & Compliance Senior Manager
Takeda
Takeda in Cambridge, MA seeks a Senior Manager, GRA Audits, Inspections and Compliance to lead global GCP audits and inspections, ensuring readiness and regulatory compliance. The role partners with Regulatory Leads and cross-functional teams to align initiatives and improve processes across neuroscience, oncology, GI and other areas. You will drive continuous improvement, manage post-audit follow-up, and support live audits, with a focus on harmonizing systems and reducing non-compliance risks. #J-18808-Ljbffr Takeda
- ...Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls... ...regulatory success and regulatory compliance. Ability to draw from precedents and... ...some supervision, plans, executes and manages regulatory submissions according to...Senior
$200.68k - $215.27k
...:JOB LOCATION: Cambridge, MAPOSITION: Senior Manager, Global Regulatory Affairs, Marketed ProductsPOSITION... ...to local company affiliates in compliance with local regulations and to maintain... ...for ensuring market access and regional GRA leads to understand market access...SeniorMinimum wageFull timeWork at officeLocal areaRemote work$212k - $333.19k
...make a lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the... ...technical support from functional stakeholders and senior management.Acts independently under the direction of a Global...SeniorMinimum wageLocal areaRemote workWorldwide- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory... ...and permits. This role helps ensure compliance with legislation and regulations, contributing... ...of executives, directors/senior managers, and managers Ensure appropriate...SeniorFull timeLocal area
- Korro is seeking an Associate Director of Clinical Data Management in Cambridge, MA to lead data management for global studies, manage CRO relationships, and ensure regulatory-compliant, audit-ready data for submissions. The role partners with Clinical Development, Biostatistics...Senior
- ...providing Quality oversight of the global post-marketing... ...development and execution of the GVP audit program as well as... ...Summary of Key Responsibilities: Senior Manager, PV QA supports all the GVP... ...system, including ensuring compliance with GVP regulations. This includes...SeniorWork experience placementRemote workWorldwide
- Job-ID31521196Reference25-04484 The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval... ...will typically collaborate, influence and negotiate with senior Nonclinical / Clinical leaders on product strategies and...Senior
- Goodwin is seeking a Senior Payroll Administrator to join the Global Operations Team. This hands-on role ensures timely... ...risk. You will collaborate with management to deliver high-quality payroll... ...and hour laws, and provide data for audits while supporting cross-training across...Senior
$124k - $335k
...to clients on tax planning, compliance, and strategy. These individuals... ...to specific PwC tax and audit guidance), the Firm's code of... ...OpportunityAs part of the Global Information Reporting team you... ...our clients' needs. As a Senior Manager you are expected to lead large...SeniorFull timeH1b$232k - $348k
...DescriptionThe Regulatory Strategy Senior Director is a regulatory... ...regulatory strategy for the assigned global or regional position and will... ...communicationsRepresents GRA on core development teams, project... .... Counsels and advises senior management on status of global Regulatory...SeniorFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$196.7k - $353.4k
...relied on to articulate clear and compelling global regulatory strategies, highlighting... ...requests for additional data, organizes and manages participation in meetings. Negotiates... ...current policies and practices in compliance with Federal and international regulatory...SeniorPermanent employmentFull timeWork at officeWork from home$128.9k - $193.3k
...contract drafting processWork closely with global accounting, finance, and commercial... ...filingsSupport quarterly and annual reviews and audits through preparation of revenue... ...present complex accounting analyses to senior management#LI-AA1At Vertex, we embrace continuous learning...SeniorFull timeContract workSummer workWork at officeLocal areaRemote workFlexible hours2 days per week$177k - $278.08k
...worldwide.This role is within in the GRA Chemistry Manufacturing &... ...success and regulatory compliance. Ability to draw from prior experience... ...team colleagues, line management, and key stakeholders are apprised... .... to ensure alignment with global regulatory requirements and...Minimum wageLocal areaRemote workWorldwide- Take the lead in shaping global pharmacovigilance quality excellence, overseeing critical audit programmes, vendor quality, and regulatory compliance activities. R&D Partners is seeking a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to provide quality...Senior
$177k - $278.08k
...initiatives across Global Regulatory Affairs... ...innovation is managed as a disciplined capability... ...aligned with GRA and Digital... ...regulatory teams, audits, inspections, and... ...Knowledge of regulatory compliance considerations (GxP... ...capabilities for senior audiences Proven...Minimum wageFull timeInterim roleLocal area$137k - $215.27k
...the best of my knowledge. Job Description About the role The Senior Manager GRA Audits Inspections and Compliance (GRAIC) - Pipeline provides expertise and support for the global management coordination and follow-up of GCP audits and inspections related...SeniorMinimum wageFull timeLocal area$216.3k - $324.5k
...Transformation & InnovationJob SummaryThe Senior Director, Regulatory Transformation... ...transformation initiatives across Global Regulatory Affairs (GRA). This Senior Director will define... ...document development, knowledge management, data utilization, and decision support...SeniorFull timeSummer workRemote workFlexible hours2 days per week3 days per week$122.25k - $176.58k
Job Title: Senior Manager, Regulatory Affairs Advertising and Promotion Location... ...and Promotion within our GRA Advertising and Promo Team,... ...advertising and promotional compliance matters. About Sanofi: We’re... ...reimbursement. Provides input to the Global organization on domestic...SeniorWork experience placement$212.03k - $318.05k
...ambition and operational execution. About the role As our Senior Director, Global Demand Planning, you'll own the LEGO demand planning capability... ...supply planning, inventory, customer planning or order management. Applied commercial and financial insight to planning...SeniorFull timeWork at officeImmediate startRelocation3 days per week- Reference: PR/609787_1789151666A global consumer products leader is seeking a Senior Global Supply Planning Manager to oversee supply planning across its apparel, accessories, and equipment portfolio. This role leads a team responsible for balancing customer demand, factory...Senior
- ...Senior Director, Global Strategic Alliances Job Description About Acquia Acquia empowers the world’s most ambitious brands to create... ...revenue, partner enablement, and executive relationship management. Working cross-functionally with Sales, Marketing, Product...SeniorLocal area
- Senior Finance & Operations Manager - J-PAL Global The Abdul Latif Jameel Poverty Action Lab (J-PAL) is an anti-poverty center that fights poverty and climate... ...complex matters. Responsible for responding to audit inquiries, providing appropriate documentation and explanations...SeniorFull timeWork at officeWorldwide2 days per week
- ...enables employees’ growth and success. As a leading global financial services company at the heart of the... ...’re seeking a future team member for the role of Senior Vice President, Regulatory Administration/ Filings Manager to join our Legal team, in Boston MA. This will be...SeniorFull timeWork experience placementWork at officeWorldwideFlexible hours
- Proclinical seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to lead quality oversight of global PV systems from Cambridge... ...of Global PV Quality Assurance and focuses on GVP compliance, audit programs, inspection readiness, and cross-functional...SeniorRemote job
- Alnylam Pharmaceuticals seeks a Sr. Manager, Global Planning to drive strategic production planning for clinical supply. The role collaborates across functions to develop scenarios and ensure plans meet program timelines and budget constraints. The candidate will lead cross...Senior
$227.9k - $308.3k
Overview:The Senior Director, Global Pharmacovigilance Quality Assurance Lead... ..., and long-term regulatory compliance.This role can be based in Cambridge... ...overseeing compliance risk management, quality metrics, trend... ....Owns the risk-based GVP audit strategy and PV assurance...SeniorFull timeTemporary workLocal areaRemote workFlexible hours- Takeda is seeking a Senior Manager, Global Regulatory Affairs, Marketed Products in Cambridge, MA to oversee regulation submissions and strategic regulatory activities for global marketed products. You will collaborate with GRL and regional leads to align with local requirements...SeniorLocal area
- ...Takeda in Boston, MA is seeking an experienced GRA CMC Product Lead to develop and oversee regulatory CMC strategies for assigned... ...meetings, mentor GRA CMC members, and drive regulatory compliance across global programs in a hybrid work model. #J-18808-Ljbffr Jobleads...
$210k - $320k
...applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead regulatory... ...dossiers (IND/CTA/MF and BLA/MAA).Plan and manage activities for the preparation of high quality CMC-related...SeniorFull timeShift work3 days per week1 day per week$195k - $330k
...valued, seen, and heard.How you’ll make an impact:Act as the global regulatory strategy lead for Kymera’s IRF5 degrader program... ..., opportunities, and recommendations to program teams and senior leadership.Manage and support junior regulatory team members, including...SeniorFlexible hours
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