Regulatory Inspection Lead - R&D Compliance & Readiness
BioSpace
Moderna is seeking a Regulatory Authority inspections expert to plan and coordinate regulatory inspections across R&D, ensuring adherence to FDA/EMA and ICH GxP standards. You will lead pre-, in-, and post-inspection activities, drive CAPA actions, and support regulatory intelligence and cross-functional study teams to maintain inspection readiness. Travel up to 30% is required; you will mentor junior staff, develop inspection management plans, and support ongoing quality culture in a #J-18808-Ljbffr BioSpace
- ...organization is seeking an Associate Director, Global Quality to oversee global quality compliance across R&D. This role involves leading compliance projects, ensuring inspection readiness, and embedding quality processes. Candidates should have a strong background in...Regulatory
- ...in Cambridge, MA, seeks a Regulatory Inspection Lead to plan and coordinate regulatory... ...(FDA, EMA) across R&D. You will build stakeholder... ...contributing to an inspection-ready culture. You will lead trainings... ...functional teams to ensure compliance and timely regulatory...Regulatory
- ...control, training program management, and compliance monitoring. This role ensures GxP... ...and personnel training records meet regulatory requirements. You will administer the... ...curricula, track QMS metrics, and support readiness for inspections as Kymera advances late-stage...Regulatory
$136k - $170k
...Summary: The Senior Manager, R&D Training System and... ...year for collaboration and regulatory inspection support. As a working leader... ...and ensuring the accuracy and compliance of all governing SOPs. The position... ...operations are always inspection ready. Work in partnership with...RegulatoryRemote work$195k - $275k
...Therapeutics is seeking an experienced professional to lead TMF management and drive compliance within clinical trials. The ideal candidate will... ...robust track record in TMF management, ensuring readiness for regulatory inspections. The role demands strong leadership, experience...Regulatory- ...The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness... ...and Skills:Knowledge of regulatory requirements and inspection expectations... ...six sigma or leanProven ability to lead improvement projects and project teams...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week
- ...Associate Director/Director, Clinical Operations Compliance to build and govern compliance across... ...issue management to ensure programs are inspection ready and compliant with GCP, ICH, FDA, and EMA. You will partner across Regulatory, Quality, Data Sciences, Clinical...Regulatory
$212k - $333.19k
..., we are a forward-looking, world-class R&D organization that unlocks innovation and... ...Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of... ...development through registration and launch readiness for high-impact oncology programs.How...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$136.4k - $253.2k
...Science is recognized as a leading hub for top industry... ...agile workforce to deliver regulatory commitments across the portfolio... ...to the TA leadYou ensure compliance and inspection readiness by establishing robust... ...experience in pharmaceutical R&D or a regulated environment...RegulatoryFull timeLocal area$144.5k - $195.5k
The Global Study Lead (Sr. Manager, Clinical... ...budget, and in compliance with applicable regulations... ..., Health Authority Inspections and internal QA... ...of inspection-readiness, collaborating with R&D Quality to ensure quality... ..., Commercial, Regulatory, Bio Analytical, Medical...RegulatoryFull timeTemporary workLocal areaRemote workFlexible hours$178.1k - $244.86k
...with enterprise priorities, regulatory requirements, and product lifecycle... ...globallyACCOUNTABILITIES Lead end-to-end strategy... ...efficient program deliveryEnsure compliance with global regulatory requirements... ...supporting audit and inspection readinessMonitor and manage program...RegulatoryMinimum wageTemporary workLocal areaNight shift- ...Associate Director of Quality Systems to lead the QMS, ensure GxP compliance, and drive continuous improvement... .... The role interfaces with CMC, Regulatory, Clinical Operations, and IT to... ...while fostering a culture of inspection readiness. Hybrid work with relocation to...RegulatoryRelocation
$148.5k - $214.5k
...MA About the job Are you ready to shape the future of... ...department within Sanofi R&D Global CMC Development organization... ...and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable... ...with agency, site inspections, or written responses to...Regulatory$120 - $170 per hour
...Research and Development (R&D), Plasma Derived... ...the overall goal of inspection readiness. Serves as a Strategic... ...quality and compliance risks to key stakeholders... ...mitigations are in place. Leads the clinical pre-... ...confirmed violations to regulatory authorities. Lead...RegulatoryTemporary workFor contractorsWork at officeImmediate startNight shift2 days per week$319.06k - $389.97k
...frameworks, and ensures sustained regulatory compliance and inspection readiness. The Vice President of Quality Systems... .... This role will develop and lead a high-performing quality team focusing... ...partner to executive leadership across R&D, Manufacturing, Regulatory Affairs,...RegulatoryFull time$34.28 - $47 per hour
...Lead Facilities Maintenance TechnicianJoining us... ...consistently meet production and compliance requirements.The role... ...on product quality, regulatory compliance, and... ...regulationsConduct safety inspections and enforce safe work... ...and ensure regulatory readiness (e.g., fire systems,...RegulatoryTemporary workFor contractorsLocal areaShift workWeekend work$125k - $130k
...crisis management, and regulatory compliance across all... ...Works with Culinary/R&D to validate new menu... ...for health department inspections and regulatory inquiries... ...Incident Management Leads investigations of foodborne... ...incidents. Manages recall readiness, traceability, and...RegulatoryLocal areaFlexible hoursShift work$103.6k - $176.4k
...working closely with R&D teams. As a Program Manager... ...the candidate will: Lead complex software... ...environments, ensuring compliance with FDA, ISO 13485, IEC... ...Engineering, Quality, Regulatory Affairs, Cybersecurity... ...documentation, and release readiness activities for...RegulatoryHourly payFull timeTemporary workSummer workMonday to FridayFlexible hours$151.2k - $226.8k
...quality records support consistent compliance across functions and regions.... ...complete, traceable, audit-ready, and meet data integrity... ...overdue items, training compliance)Lead QMS simplification/... ...environmentsExperience supporting QMS-related inspections and audits QMS design,...- ...training. Conduct pre-departure inspections and ensure vessels are ready for operation. Monitor vessel... ...and equipment. Coordinate with regulatory agencies, marinas, ports, and support... ...vessels when required. Ensure compliance with all USCG regulations and...RegulatoryFull timeWork at officeRemote workFlexible hours
$247.2k - $334.4k
The Senior Legal Director, R&D and Regulatory Counsel is a strategic legal leader who enables... ...and enhanced oversight of clinical compliance frameworks.Reporting to the... ...liability, privacy, pharmacovigilance, inspection readiness, and human subject research protections...RegulatoryFull timeTemporary workLocal areaFlexible hours$140k - $185k
...CRCL) is one of the world’s leading internet financial platform... ....As a Lead Analyst, Product Compliance supporting Circle’s Payments... ...operated in alignment with regulatory expectations and internal compliance... ...driving cross-functional readiness for domestic and cross-...RegulatoryFlexible hours- Emergent Biosolutions in Canton, MA is searching for a Sr. Manager, QA Compliance to ensure GMP compliance and regulatory inspection readiness. This role is pivotal in leading internal audits and supplier quality oversight, ensuring alignment with global standards. The...Regulatory
$142.3k - $195.7k
...part of our caring communityThe Lead Solutions & AI Enablement... ...Collaborate with governance and compliance teams to validate designs... ...against enterprise standards and regulatory requirements.Define... ...decision forums to support delivery readiness and quality assurance.Demonstrated...RegulatoryFull timeTemporary workFor contractorsWork at officeRemote workWork from homeHome office$65 - $85 per hour
...| Yoh ***W2 candidates only*** REMOTE EST HOURS // Lead Systems Data Analyst - Regulatory Compliance Monitoring, Investment/Asset Management, Data Governance... ..., investment guideline management, and data readiness across investment management platforms. This role is...RegulatoryRemote work$252k - $269k
...quality programs to ensure compliance across global... ...the organization is ready for inspections, implements and manages... ...respond to evolving regulatory expectations. Strategic... .... Develop and lead Risk Management assessments with Clinical R&D and commercial safety...RegulatoryLocal areaWorldwide$275k - $315k
...experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy... ...global regulatory plans.Ensure compliance with applicable global... ...SOP requirements; maintain audit-ready regulatory documentation and inspection readiness.QualificationsBachelor...RegulatoryFull timeTemporary workWork at officeLocal area3 days per week- ...Quality Inspector will support QC Incoming Inspection and Review & Release activities to ensure compliance with internal procedures, regulatory requirements, and quality standards.... ...to detail, documentation, and readiness to participate in #J-18808-Ljbffr Integra...Regulatory
- ...operational standards and compliance leadership for... ...Medical Governance Office lead for evidence... ...risk management and inspection readiness across Medical-led research... ...while partnering with R&D Quality Assurance as... ...& Compliance, Legal, Regulatory, Pharmacovigilance, Digital...RegulatoryMinimum wageFull timeTemporary workWork at officeLocal area
- ...Therapeutics is seeking a Senior Manager, R&D Training System and Operations to co-... ...and Ohio for collaboration and regulatory inspection support. The successful candidate balances... ...remain compliant, scalable, and inspection ready across GLP, GCP, GCLP, GVP, GRP, and GPP...RegulatoryRemote job
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