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Regulatory Affairs Remote Jobs

131 fresh jobs found

Senior Director/Director of Global Regulatory Affairs (Onsite/Remote)
Sunnyvale, CA, US

EBR Systems, Inc.

Regulatory Budgeting Global Regulatory Strategy Resource Planning Regulatory Affairs Team Development Performance Management Stakeholder engagement Risk Management Cross-functional Collaboration +2

Senior Full Time

USD 176K+

Senior Director, Clinical Pharmacology
New York, New York

Axsome Therapeutics Inc

Winnonlin Modeling and simulation software Nonmem Pharmacodynamics CNS Disorders Pharmacokinetics Clinical Trial Design Good Clinical Practice Protocols +11

Senior Full Time

USD 245K+

Director, Clinical Pharmacology Lead
USA - Pennsylvania - Plymouth Meeting, Amerika Birleşik Devletleri

Biomarker Strategy Modeling and Simulation Pharmacometrics Pharmacodynamics Translational Medicine Pharmacokinetics Clinical Pharmacology Study Design ICH +14

Senior Full Time

USD 150K+

Senior Director, Clinical Development, Solid Tumors Breast Franchise
Remote (US), United States

Medical Support Translational Research Biometrics Clinical Oversight Clinical Study Reports Budget planning Scientific Expertise Molecular diagnostics Compliance Guidelines +40

Senior Full Time

USD 287K+

Senior Director, Global Value Access & Pricing, Solid Tumors
Remote (US), United States

Health economic models Clinical Trial Design Outcomes Research Evidence Generation Commercial Strategy Health Economics Strategic vision Pricing strategy Incentive Compensation +33

Senior Full Time

USD 214K+

Executive Director, Quality Assurance
USA - Pennsylvania - West Point, United States

Forecasting and planning GMP activities Process ownership Cross-divisional collaboration Global Regulatory Affairs Clinical supply chain Translational Medicine Matrix organization Digital innovation +76

Exec Senior Full Time

USD 227K+

Regulatory Manager
Remote, United States

Precision for Medicine

Clinical Study Interpretation Scientific Advice Drug development process ICH GCP Regulatory strategy Regulatory Guidance Pharmaceutical Development ICH Precision Medicine +21

USD 106K+

Regulatory Manager
Remote, United States

Precision Medicine Group

Clinical Study Interpretation Scientific Advice Timeline development ICH GCP Regulatory strategy Regulatory Guidance Pharmaceutical Development ICH Precision Medicine +25

USD 106K+

Quality Engineer - SaMD
Remote, United States

Medical device QMS Nonconformance evaluations External audits FDA CFR 21 820 21 CFR Part 820 Design Validation Process controls Internal Audits Design verification +51

USD 84K+

Regulatory Advisor, Energy & Utilities
Maryland Remote Office (MD99), United States

ICF Remote-first

Smart grid services Regulatory strategy development Data request responses Ghg emission reductions Utility regulation Building electrification Filing preparation Flexible load management Electric Vehicles +59

USD 89K+

Staff Regulatory Affairs Specialist
Remote US

SOP Authoring AI/ML in Healthcare Global Product Registration Submission Preparation Compliance review Regulatory Intelligence Wearable technology 21 CFR 820 EU MDR +20

Senior Full Time

USD 124K+

Principal Scientist, Translational Medicine, Immunology
USA - Massachusetts - Boston (MA Parcel B Laboratory), United States

Drug Metabolism Experimental Medicine Global Clinical Trials Operations Scientific background Target identification Modeling and Simulation Metabolism Early clinical development Biomarker Strategies +67

Senior Full Time

USD 255K+

USCAN Head of Drug Safety and Pharmacovigilance
Remote, United States

Global safety database Office packages Argus Chatbots Drug Safety Claude Pharmacovigilance FDA Regulatory Affairs +29

Exec Senior Full Time

USD 160K+

Senior Specialist, Quality Assurance - Hybrid
USA - Pennsylvania - West Point, United States

Packaging operations Global Regulatory Affairs Current good manufacturing practices Clinical supply chain Contract Manufacturing Quality Risk Management Manufacturing Practices Device development Good Manufacturing Practices +63

Senior Full Time

USD 104K+

Sr Translational Med Scientist
US Remote

Circulating nucleic acids Early cancer detection Fragmentation SNV/indel panels Methylation Genomic analysis HIPAA/PHI Privacy Strong organizational PHI Privacy +46

Senior Full Time

USD 106K+

Diagnostic Regulatory Affairs Manager
US - California - Thousand Oaks - Field/Remote, United States

Clinical Regulatory Guidance Regulatory Document Management Health Agency Regulations Strategic outcomes Health authorities Companion diagnostics Regulatory Strategies Registration In vitro diagnostics +22

USD 112K+

Senior Principal Scientist, Translational Medicine, Immunology
USA - Massachusetts - Boston (MA Parcel B Laboratory), United States

Drug Metabolism Experimental Medicine Global Clinical Trials Operations Target identification Modeling and Simulation Early clinical development Metabolism Biomarker Strategies Lead optimization +72

Senior Full Time

USD 281K+

Software Design Assurance Quality Engineer
US Remote, United States

Medical device standards Firmware Development Software validation IEC 62304 Design control Medical device industry Neuromodulation ISO 13485 Medical Technology +20

USD 115K+

Digital Scientific Project Manager
US - Morristown, NJ - REMOTE, United States

Scientific content creation Formulation science Digital Product Development Digital Commerce GMP Regulatory Affairs Regulatory standards R&D Industry trends +18

USD 100K+

Cloud Platform Design Assurance Engineer
US Remote, United States

Design control regulations VNS Therapy Cloud data management Software validation Mobile Device Management Medical Device Solutions Vagus Nerve Stimulation Therapy Vagus Nerve Stimulation Medical device industry +24

Senior Mid Full Time

USD 110K+

AI/ML Specialist
US Remote, United States

Medical Technology Regulatory Submissions Predictive Modeling SOPS Regulatory Affairs Healthcare systems Quality Management Statistical analysis Medical device +22

Senior Full Time

USD 140K+

Director, Clinical Scientist - Respiratory
Remote

Apogee Therapeutics

Study Protocols Patient Population Selection Safety Monitoring Clinical study design Antibody Engineering Clinical Trial Design Scientific Expertise Study Design Pharmacovigilance +21

Exec Senior Full Time

USD 200K+

Senior Director, Late-Stage Readiness Lead
Remote

Apogee Therapeutics

Submission readiness Antibody Engineering Biologics Immunology Regulatory Affairs Smartsheet Clinical operations Drug Development Clinical Development +12

Senior Full Time

USD 250K+

Manager, Clinical Supply Chain Management
Remote

Apogee Therapeutics

Label Development Clinical Supply Chain Management Drug Product Delivery Simulation Tools Antibody Engineering Technical Operations SOP Development Logistics Management GMP +14

USD 140K+

Director of Public Healthcare and Payor Compliance
United States - Remote

Kestra Medical Technologies, Inc

State laws Audit Management Emotional Intelligence Regulatory Affairs Customer focus Revenue Cycle Management Training Development Contract management Confidentiality +13

Exec Senior Full Time

USD 185K+

Senior Manager, Regulatory Affairs Device
Cambridge, MA, United States

Sarepta Therapeutics

Global Regulatory Strategy Gene editing RNA Gene therapy Regulatory strategy ICH Guidelines Documentation Management ICH Regulatory Submissions +8

Senior Full Time

USD 132K+

Senior Regulatory Affairs and Market Development Analyst
Nationwide Remote Office (US99), United States

ICF Remote-first

Utility customer experience Non-wires alternatives Integrated systems planning Flexible load management Electric vehicle programs Non-pipes alternatives Distribution Planning Beneficial electrification Utility industry +39

Senior Full Time

USD 81K+

Associate Director, Regulatory Affairs - Remote
USA CA - San Diego Bldg A&B, United States

Medical Device Regulations Labeling New Product Development Cross-functional Teamwork Regulatory Submissions Regulatory Affairs R&D Microsoft Office Suite Microsoft +19

Senior Mid Full Time

USD 169K+

Director, Regulatory Intelligence and Policy, PDX
Remote, United States

Regulatory Intelligence Regulatory strategy Pharma Regulatory Affairs Digital solutions Policy Development Influence Advocacy Influencing +21

Exec Senior Full Time

USD 148K+

Senior Compliance Analyst - ICHRA
Remote-MO, United States

Centene Corporation

Health plan compliance Regulatory Interpretation Regulatory filings Compliance monitoring Health Plan Training Programs Risk assessments Regulatory Affairs Policy Development +23

Senior Mid Full Time

USD 68K+

Regulatory Operations Project Manager, Product Environmental Compliance (Remote)
California, San Jose 5900 Optical Ct, United States

Product environmental compliance International regulations Statistical Process Controls Regulatory strategy M Biology Process Development Quality Management System Regulatory Affairs +25

Senior Full Time

USD 113K+

Director Global Regulatory Affairs - Precision Medicine and Digital Health
USA - MA - Virtual, United States

Scientific data interpretation Global health authorities Diagnostic tests Digital Health Tools Line management Global Regulatory Affairs EMA Global Regulatory Strategy Device development +21

Exec Senior Full Time

USD 169K+

Director, GHEOR Patient-Reported Outcomes Assessment (PROA) - Hematology/Oncology
Field - United States, United States

Bristol Myers Squibb

Publication strategy Clinical outcomes assessment Psychometrics Cell Therapy Outcomes Research Health Economics FDA Hematology Regulatory Affairs +16

Exec Senior Full Time

USD 211K+

Director, Global Regulatory Lead
Remote (US), United States

Market Approval Marketing approval Global Regulatory Requirements Global Regulatory Strategies Regulatory Documentation Global Regulatory Affairs Health Authority Interactions Drug development process Regulatory strategy +48

Senior Full Time

USD 171K+

Senior Director, Regulatory Affairs Advertising & Promotion
5000 - Vertex US - Boston, United States

Vertex Pharmaceuticals

Promotional Communications Advertising Regulations Communication Review Product Labeling Clinical study design Medical Review Commercial Strategy Cross-functional Leadership Regulatory Affairs +16

Senior Full Time

USD 216K+

Complaint Investigator
US-AZ-Remote Location, United States

Agilent Technologies

Workflow troubleshooting IVD Complaint Management 21 CFR 820 Product safety Biological sciences ISO 13485 Materials Instrumentation +24

USD 67K+

Principal Regulatory Affairs Specialist/Engineer (SaMD)
Virtual US

Cleerly Remote-first

De novo requests CE marking 510k FDA Submissions Sheets Regulatory strategy ISO 14971 Drive FDA regulations +32

Senior Full Time

USD 179K+

Associate Director, Biologics Manufacturing Management
Somerville, MA · United States - Remote

Biologics Manufacturing CMC Strategy External Manufacturing Management Cross-Functional Team Collaboration Regulatory Affairs Process Optimization Quality Control Technical Expertise Contract Negotiation +10

Senior Mid Full Time

USD 168K+

Manager of Regulatory Affairs
CAN - ON - Remote, Canada

AmerisourceBergen

Microbiology Liaison Mathematical Cross-functional Teamwork Adobe Acrobat CAD Regulatory Submissions Biology Regulatory Affairs +28

CAD 79K+

Associate Director, Global Pharmacovigilance Quality Management
Cambridge, MA, United States

Sarepta Therapeutics

Gene editing RNA MS Visio Gene therapy Systems Thinking Pharmacovigilance ICH Regulatory Affairs Quality Management +9

USD 156K+

US Lead, Medical Information & Medical Review (Remote)
Ridgefield, CT, United States, Connecticut

Boehringer Ingelheim

Digital Communication Medical Review Medical Information Regulatory Affairs Clinical Development Pharmaceutical Industry Medical Affairs Insights Budget management +10

Senior Full Time

USD 220K+

Vice President, Global Regulatory Affairs
US-MD-Remote Location, United States

Agilent Technologies

Product Registration Regulatory Intelligence Medical device development ISO Standards Chemical Environmental Regulatory Affairs Stakeholder communication Medical device +17

Exec Senior Full Time

USD 244K+

Regulatory Affairs Manager
Newport Beach, California, United States

Regulatory Submission Document Preparation Detail Orientation IT systems GMP Regulatory Affairs Planning Project Management Organizational +2

USD 125K+

Manager/Senior Manager, Regulatory Affairs
Chicago, IL

CAP/CLIA Software validation Clinical decision support Good Clinical Practice Quality Systems ISO 13485 Clinical Care Bioinformatics CAP +25

Senior Full Time

USD 110K+

Medical Writer, Scientific Communications
Your Remote US Home Office

Abstract writing Manuscript preparation Clinical Study Management Compliance principles Data evaluation Medical Writing Presentation Development Scientific communication Quality Management System +14

USD 120K+

Global Director of Clinical Science
Remote California, United States

Clinical evaluation Continuous Glucose Monitoring Medical Writing Matlab Clinical Studies Regulatory Submissions Health Technology Regulatory Affairs SAS +23

Exec Senior Full Time

USD 199K+

Head of Government Affairs
Chicago, United States

Financial services regulation Retirement policy Credit ratings Policy Research Securities Law Lobbying Government Affairs Public Policy Regulatory Affairs +14

Exec Senior Full Time

USD 176K+

Corporate Investigator
USA - PA - Remote, United States

AmerisourceBergen

Report Analysis Strong interpersonal Security audits Liaison Interviewing Investigations Due Diligence Regulatory Affairs Audits +18

Senior Full Time

USD 72K+

Manager/Sr. Manager, Regulatory Publishing & Operations
Remote - United States

Regulatory Operations EU Submissions Veeva RIM Submission Management FDA Submissions Clinical Studies Document management Regulatory Submissions Regulatory Affairs +9

Senior Mid Full Time

USD 135K+

Associate Director, Regulatory Affairs and Submissions
Site Kansas - 10103 Metcalf Ave, United States

Health Canada Guidelines Submission Preparation GCP compliance FDA guidelines ICH Guidelines SOP Development Gap Analysis Regulatory Affairs Drug Development +7

Senior Mid Full Time

USD 101K+

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