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Verona, Wisconsin, United States (Verona, WI) permanent
Regulatory AffairsComplianceGlobal RequirementsRisk-Based ApproachRegulatory StrategyAutomation TechnologiesManufacturing SupportScientific PrinciplesPost-Approval Change ManagementICH Q12 Principles

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a br...

May 6, 2026 View Details
India - Bangalore permanent
Regulatory AffairsProject ManagementInternational CollaborationRisk ManagementChange ManagementComplianceLXPCross-Functional LeadershipRegulatory Strategy DevelopmentCMC Submissions

Job Title: International CMC Regulatory Affairs Associate Director I Global Career Level:E1 Introduction to role This role leads and manages complex iCMC projects and product ranges across the port...

April 14, 2026 View Details
India - Bangalore permanent
Regulatory StrategyCMC ExpertiseProject ManagementHealth Authority CollaborationRegulatory SubmissionsRisk ManagementResearch SkillsChange ManagementBusiness Process OptimizationGxP Principles

Introduction to role: Are you ready to turn breakthrough science into approved medicines faster? Do you thrive at the intersection of CMC excellence, regulatory strategy, and real-world impact for pa...

March 17, 2026 View Details
India - Bangalore permanent
Regulatory StrategyCMC ExpertiseProject ManagementRegulatory SubmissionsHealth Authority CollaborationRisk ManagementRegulatory ExpertiseChange ManagementResearch SkillsProcess Optimization

Introduction to role: Are you ready to turn breakthrough science into approved medicines faster? Do you thrive at the intersection of CMC excellence, regulatory strategy, and real-world impact for pa...

March 17, 2026 View Details
Remote Remote permanent
Regulatory StrategyRisk ManagementGlobal Health AuthoritiesDocument PreparationRegulatory DocumentsPolicy DevelopmentTeam LeadershipCross-functional CollaborationFDA InteractionGxPs Compliance

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innova...

February 25, 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
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
San Diego, CA permanent
Regulatory AffairsCMCFDAICHEMABLAStability DataComparability ProtocolsProcess ValidationRegulatory Strategy

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramioc...

February 4, 2026 View Details
San Diego, CA permanent
Strategic LeadershipRegulatory StrategyGlobal ComplianceRisk ManagementRegulatory Filing PreparationRisk IdentificationCross-Functional CollaborationRegulatory AlignmentProduct Labeling

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramioc...

February 4, 2026 View Details
India - Bangalore permanent
Regulatory AffairsCMC DocumentationProject ManagementRegulatory StrategyHealth Authority ComplianceRegulatory IntelligenceRisk ManagementChange ManagementResearch SkillsGxP Principles

Job Title: CMC Regulatory Affairs Manager II Global Career Level: D2 Introduction to role: Are you ready to turn complex CMC data into clear, timely regulatory strategies that speed transformative t...

January 29, 2026 View Details
2 Locations permanent
Regulatory AffairsInternational CMCPharmaceuticalsComplianceStrategic LeadershipCross-functional CollaborationRegulatory StrategyQuality AssuranceSubmission ManagementGlobal Regulatory Networks

The Head of (Executive Director) International CMC Regulatory Affairs reports to the VP International Regulatory Affairs and is accountable for leading a team of Regulatory professionals (7-10 direct ...

January 4, 2026 View Details