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Regulatory Affairs CMC

ArtechInformationSystemLLC

Westborough, MA, United States contract
Regulatory AffairsCMCDossier PreparationDocument PreparationRegulatory ComplianceGlobal Regulatory StrategiesRegulatory SubmissionsRegulatory Compliance Administrative SupportInteract cross-functional teamsProject Support

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate ...

December 23, 2015 View Details

CMC Project Manager

ArtechInformationSystemLLC

King of Prussia, PA, United States permanent
Pharmaceutical IndustryProject ManagementCMCSafetyDispositionSupply ChainChemistryRegulationsRisk ManagementBudgeting

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate ...

July 8, 2016 View Details
Ludwigshafen, RP, Germany permanent
LeadershipStrategic PlanningCMMS SystemsRegulatory AffairsCross-functional CollaborationRisk ManagementProject ExecutionRegulatory Agency RelationsQuality AssuranceScientific Leadership

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

October 9, 2025 View Details
Ludwigshafen, RP, Germany permanent
LeadershipStrategic PlanningCMMS SystemsRegulatory AffairsTeam LeadershipRegulatory Agency RelationsQuality AssuranceRisk ManagementProduct DevelopmentRegulatory Strategy

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

October 9, 2025 View Details
Minato-ku, 13, Japan permanent
Regulatory AffairsStrategic PlanningSubmission ManagementCross-functional CollaborationRegulatory LiaisonRegulatory MonitoringRegulatory Project ExperiencePatient RegistrationCommunication

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

December 4, 2025 View Details
North Chicago, IL, United States permanent
Regulatory AffairsCMCStrategic PlanningRegulatory StrategyRegulatory SubmissionsRegulatory Agency RelationsChange ControlManufacturing ProcessesProduct DevelopmentTeam Collaboration

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

January 9, 2026 View Details
North Chicago, IL, United States Hybrid permanent
Regulatory AffairsCMC Control Strategy CollaborationRegulatory SubmissionsRegulatory AnalysisRegulatory CollaborationChange RequestsRegulatory ComplianceRegulatory KnowledgeRegulatory TrendsProject Management

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

January 23, 2026 View Details
North Chicago, IL, United States permanent
Biologics DevelopmentScientific LeadershipAnalytical TestingChromatographyHigh-Resolution Mass SpectrometryProject ManagementCross-functional CollaborationRegulatory AffairsScientific Publications

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

February 2, 2026 View Details
North Chicago, IL, United States Hybrid permanent
Dossier PreparationSource Information GatheringData-Rich Content AuthoringCMC Control Strategy CollaborationQuality AssuranceProcess ImprovementStakeholder RepresentationIT tools integration

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

February 3, 2026 View Details
Worcester, MA, United States Hybrid permanent
Dossier PreparationSource Information GatheringData-Rich Content AuthoringCMC Control Strategy CollaborationQuality ChecksProcess ImprovementStakeholder RepresentationAutomation Development

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

February 3, 2026 View Details
South San Francisco, CA, United States Hybrid permanent
Regulatory KnowledgeDossier PreparationScientific WritingData ManagementProcess ImprovementTeam CollaborationAutomation ToolsQuality AssuranceStakeholder ManagementRegulatory Compliance

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

February 3, 2026 View Details
South San Francisco, CA, United States permanent
PhDChemistryCell CultureMammalian Cell CultureProtein TherapeuticsBioprocess DevelopmentMolecular TechniquesProtein Separation

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

February 4, 2026 View Details
North Chicago, IL, United States permanent
Analytical TestingProtein LabelingHigh-Resolution Mass SpectrometryAntibody Structural VisualizationADC Aggregation CharacterizationCollaborationIndependent Experiment DesignDrug HandlingAggregation Mechanism Understanding

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

February 5, 2026 View Details
Annapolis, MD (Lanham, MD) permanent
Patient CareEMR SystemsHIPAAWound Ostomypressure-handlingInterdisciplinary CollaborationISO DocumentationEducation and Precepting

Position Objective: The Wound Ostomy Nurse (WON) or Wound Ostomy Continence (WOC N) serves as the clinical resource and consultant for the acute care setting within the hospital relative to the care ...

February 5, 2026 View Details
Lanham, MD permanent
Patient CareClinical LeadershipTeam ManagementInventory ManagementBudget ManagementCommunicationEducationRegulatory Compliance

Position Objective: Contributes to the provision of high quality, cost-effective patient care and collaboration with other health care team members, with emphasis on designated service lines. Serves ...

February 5, 2026 View Details
Annapolis, MD (Lanham, MD) permanent
Staff-Patient Family RelationshipsClinical ScholarshipClinical Leadership

Position Objective: Contributes to the provision of high-quality, cost-effective healthcare as a provider of direct and indirect patient care and by effective of the health care team. Functions as a ...

February 5, 2026 View Details

CMC Project Manager

IntegratedResourcesINC

Lexington, MA, United States contract
Project ManagementRegulatory SubmissionChange ManagementCross-functional CollaborationCommunicationRisk ManagementStakeholder EngagementProject PlanningTeam CoordinationAgile Methodologies

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellen...

May 1, 2015 View Details
Lexington, KY, United States permanent
Regulatory AffairsProject ManagementCMCOncology SubmissionGlobal Health Authority InteractionProject PlanningDocumentationTimelinesCommunicationDetail-Oriented

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellen...

May 20, 2015 View Details
Lexington, MA, United States contract
Regulatory ComplianceDirectory SubmissioneCTD SubmissionsRegulatory Submission TimelinesCMCQuality AssuranceProcess OptimizationTraining and DevelopmentRegulatory Trends

A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excell...

June 24, 2015 View Details
Lexington, MA, United States contract
Regulatory AffairsCMCFDAhealthKitProduct DevelopmentQAQAQCManufacturingRegulatoryGuidelinesRegulatory StrategyRegulatory DocumentationChange Control Processes

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellen...

October 23, 2015 View Details

Manager Regulatory Affairs-CMC

IntegratedResourcesINC

Lexington, MA, United States permanent
Regulatory AffairsICH GuidelinesCTD WritingGlobal AffairsInternational RecruitmentCore DossierPharmaceutical IndustryBiologicsSmall MoleculeDrug Development

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integri...

August 24, 2016 View Details
Ho Chi Minh, Tan Phu, Vietnam contract
Talent AcquisitionEmployee EngagementPerformance Management

Eurofins Scientific through its subsidiaries is a world leader in food, environment, pharmaceutical and cosmetic product testing, discovery pharmacology, forensics, advanced material sciences, and in ...

January 22, 2026 View Details

CMC Regulatory Affairs Manager

IntegratedResourcesINC

Waltham, MA, United States contract
Regulatory AffairsBiologicsRegulatory SubmissionsRisk AssessmentStrategic PlanningComplianceGuidelinesRegulationsOrganizational SkillsCommunication

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integri...

August 24, 2017 View Details
St. Gallen, SG, Switzerland permanent
Original Design ManufacturerCDMO collaborationGMP TestingBatch recordsInvestigationsChange Control ProcessesProduct KPIsAPI specificationsSOP updates

Eurofins Scientific is an international life sciences company that offers customers from various industries a unique range of analytical services to make life and our environment safer, healthier and ...

January 30, 2026 View Details
Boston, MA, United States permanent
Mammalian Cell CultureSingle Cell AssaysPCRLaboratory Information SystemsTesting CoordinationSOP ComplianceAttention to DetailCritical AnalysisProactiveness

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break...

February 2, 2026 View Details
Ho Chi Minh City, Ho Chi Minh City, Vietnam Hybrid permanent
SQLDatabase AdministrationDatabase ConfigurationConfigurationUpgradePerformance MonitoringPrecision Tune-upsPerformance Optimization

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, he...

February 3, 2026 View Details
San Antonio, TX, United States contract
Tactical Combat Medical CareVeterinary ServicesTraining AdherenceTesting OversightHealthcare InterventionsEmergency ResponseAnimal ModelsHospital GuidelinesOrientationContinuing Education

ProSidian is a Management and Operations Consulting Firm focusing on providing value to clients through tailored solutions based on industry-leading practices.  We help forward-thinking clients solve ...

January 9, 2019 View Details
Ho Chi Minh City, , Vietnam permanent
PythonMachine LearningLarge Language ModelsData AnalysisProduction CodeCross-functional CollaborationTrend Awareness

The Bosch Group is a leading global supplier of technology and services. Its operations are divided into four business sectors: Mobility, Industrial Technology, Consumer Goods, and Energy and Bui...

November 26, 2025 View Details
Wright-Patterson Air Force Base, Ohio, United States permanent
Supply Chain ManagementLogisticsSpares Requirements Review BoardDemilitarizationService Catalog DevelopmentCritical Items IdentificationDiminishing Manufacturing SourcesChief Financial Officer ReportingBasic Materials ManagementSupply Replenishment

Overview At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence ca...

November 3, 2025 View Details
WPAFB, Ohio, United States permanent
Test ManagementStrategic PlanningMentoringLeadershipBudget PlanningRisk ManagementDocumentationVendor CoordinationProject ManagementRequirements Analysis

At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence capabilities...

November 20, 2025 View Details
Hanscom Air Force Base, Massachusetts, United States permanent
SecurityRequirements DevelopmentLOAETSISite VisitsInspectionsAdministrative TasksAnalytical AbilitiesTechnical Assistance

Overview At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence ca...

February 2, 2026 View Details
Oklahoma City, Oklahoma, United States permanent
LogisticsProject ManagementResource ManagementRisk ManagementTechnology ModernizationSystems AnalysisDocumentationDecision MakingProblem SolvingTeam Leadership

Overview At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence ca...

November 17, 2025 View Details
WPAFB, Ohio, United States permanent
CommunicationProblem SolvingAnalysisRecommendationProject ManagementMicrosoft OfficeMicrosoft WordMicrosoft ExcelDatabase ManagementReport Writing

At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence capabilities...

December 15, 2025 View Details
Oklahoma City, Oklahoma, United States permanent
Program ExecutionCoordinationReportingData AnalysisProject ManagementTrainingTravel Management

Overview At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence ca...

January 30, 2026 View Details
Hanscom Air Force Base, Massachusetts, United States permanent
COMSECIT SecurityNetwork DocumentationWindows NetworkWeb ServicesData DigitizationDoD Internet ApplicationsFirewallsReliable Internet AccessSecurity MonitoringSystem Documentation

Overview At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence ca...

February 3, 2026 View Details
WPAFB, Ohio, United States Remote permanent
Fire Protection EngineeringPlanningDesign ReviewProblem SolvingTechnical ExpertiseCost EstimationTechnical DrawingsSpecificationsCoordinationCustomer Support

Overview At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence ca...

October 22, 2025 View Details
WPAFB, Ohio, United States permanent
Financial AccountingBudgetary ControlsInternal Accounting ControlsFinancial AuditDoD ComplianceContract AmendmentsData AnalysisRisk ManagementLeadership

Overview At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence ca...

February 2, 2026 View Details
WPAFB, Ohio, United States permanent
LogisticsUI UX DesignProduct SupportMaintenance PlanningSustainable EngineeringComputer BasicsMechanical InfrastructurePersonnel ActivitiesTrainingRisk Management

Overview At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence ca...

December 19, 2025 View Details
WPAFB, Ohio, United States permanent
Configuration ManagementChange ControlVersion ControlArtifact RecoveryDocumentationCode LibrariesAutomated BuildBusiness ScriptsJob ChangesTechnical Contract Management

Overview At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence ca...

December 12, 2025 View Details
WPAFB, Ohio, United States permanent
Knowledge AcquisitionIntelligence AnalysisSIGINTHUMINTColiseum ProductionSCIFJWICSSIPRNetCyber Resilience

Overview At Credence, we support our clients’ mission-critical needs, powered by technology. We provide cutting-edge solutions, including AI/ML, enterprise modernization, and advanced intelligence ca...

November 21, 2025 View Details
Boston, Massachusetts (Pulmovant) Remote permanent
QCMethod VerificationRelease TestingStability StudiesRegulatory DocumentationDevelop StrategiesVendor ManagementAnalytical Techniques and TechnologyInhaled Product DevelopmentCross-functional Collaboration

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant’s first program, mosliciguat is designed to...

February 4, 2026 View Details
Waltham, MA (USA) Hybrid permanent
Regulatory AffairsCMCChemistryManufacturingControlsSmall MoleculeAPIDrug-Device Combination ProductsRegulatory SubmissionsQuality

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Ou...

January 30, 2026 View Details
Pittsburgh, Pennsylvania, United States (ElevateBio) permanent
Project ManagementCross-Functional CollaborationRisk ManagementProcess DevelopmentcGMP ComplianceFinancial ManagementCommunicationDecision MakingProcess StandardizationKPI Management

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model ...

January 31, 2026 View Details
US Remote (Remote - US) Remote permanent
Strategic LeadershipCross-Functional Collaboration

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive...

February 4, 2026 View Details
United States - Remote Remote permanent
Regulatory AffairsCMCChemistryManufacturingASOIND PreparationNDAsBLAsGlobal Health Authority InteractionProject ManagementCommunication

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity The Senior Manager, Regulatory CMC will be responsible for the pl...

January 19, 2026 View Details

Senior Director, CMC Regulatory Affairs

Praxisprecisionmedicines

United States - Remote Remote permanent
Regulatory AffairsCMCInvestigational ProductsCommercial FocusASO TherapeuticsIND PreparationNDC AssignmentRegulatory ComplianceGlobal Health Authority InteractionProcurement Process OversightPost-Approval ChangesElectronic Transfers

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity The Senior Director, Regulatory CMC will provide strategic and op...

January 19, 2026 View Details
United States - Remote Remote permanent
Strategic LeadershipRegulatory ComplianceQuality CommitmentRisk ManagementQuality SystemsChange ControlDeviation ManagementSite InvestigationTemperature Excursion ManagementCAPA ProgramsProduct Quality ComplaintsChange Management

Location: This position may be performed remotely with travel to the Boston area as needed. Requires ability to travel domestically and internationally to meet program needs (estimated 15-20%).  Posi...

February 4, 2026 View Details

Sr. CMC Project Manager

Apogeetherapeutics

Remote Remote permanent
Project ManagementDocumentationSharePointVeeva Quality SystemProcurementResource ManagementRisk ManagementCross-functional CollaborationFinancial Systems

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environ...

January 6, 2026 View Details
Remote Remote permanent
Regulatory AffairsCMCBiologicsDrug-Device Combination ProductsRegulatory SubmissionsNotified BodiesRisk Management ConsultingRegulatory StrategyRegulatory ComplianceProcess Optimization

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environ...

December 16, 2025 View Details
Lanham, MD permanent
Patient CareMedication AdministrationEMR SystemsHIPAA ComplianceNursing DocumentationPatient AssessmentsRoutine ProceduresPhlebotomyCPR

Overview: The nursing graduate shall practice only under the direct supervision of a registered nurse who is physically present on the unit to (1) cosign medication transcription, medication administ...

February 4, 2026 View Details