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Regulatory Affairs Remote Jobs

127 fresh jobs found

Program Coordinator, Policy & Regulatory Affairs
Seattle Washington, United States, United States

Logistics Management Public Policy Regulatory Affairs Administrative Support Time Management Project Management Organizational Communication

Senior Mid Full Time

USD 88K+

Study Start-Up Manager (Remote)
Remote Position (USA), United States

Site selection Patient Enrollment Matrix management Matrixed environment ICH Drug Development FDA Regulatory Affairs Clinical operations +21

Senior Mid Full Time

USD 114K+

Associate Director, Global Medical Communications
United States - Remote

Slide Deck Creation Medical Communications Medical Writing Patient advocacy Regulatory Affairs Advocacy Vendor Management Communications Cross-functional Collaboration +4

USD 185K+

Associate Director, Quality Assurance
USA - New Jersey - Rahway, United States

Quality investigations Drug Product Manufacturing Preventive Actions Regulatory inspections Deviations Equipment qualification Quality Risk Management Formulation Materials Management +84

Senior Mid Full Time

USD 126K+

Associate Director, Quality Assurance - Hybrid
USA - Pennsylvania - West Point, United States

Global Regulatory Affairs Clinical supply chain Clinical trial operations Clinical Supply Clinical supplies Operational Management Standard Operating Procedures Operational Key Performance Indicators +41

Senior Mid Full Time

USD 126K+

CRP Allergy Global and US Medical Affairs
US: USA Remote, United States

Eli Lilly and Company

Medical Support Data Dissemination Clinical trial data Medical research Good clinical practices Clinical Pharmacology Patient Safety Legal counsel Payer +55

Senior Full Time

USD 198K+

Artwork Senior Manager
United States Remote Office, United States

Miro boards Artwork operations Gxps Lucid Charts Presentational GVP TrackWise Smartsheets Business process mapping +25

Senior Full Time

USD 95K+

Manager Clinical Trials (Remote) - Neurology
Remote - Missouri, United States

Washington University in St. Louis

Investigator meetings Timelines management Investigational sites Cognition Quality oversight ICH Guidelines Pharmacovigilance Federal regulations Biostatistics +17

Entry Mid Full Time

USD 75K+

Sr./Director, Regulatory Affairs
Virtual US

Cleerly Remote-first

FDA Submissions CE marking Slides Docs Regulatory strategy Sheets Drive Gmail FDA regulations +30

Senior Full Time

USD 210K+

Director of Chemical, Environmental and Biological Regulatory Affairs
US-DE-Remote Location, United States

Agilent Technologies

SDS Reviews Lifecycle Support Biological Regulations Labeling Reviews Hazcom Management Chemical regulations Product stewardship Environmental regulations New Product Development +20

Exec Senior Full Time

USD 150K+

Senior Manager, R&D Quality Operations & Excellence (Strategy & Structure)
Remote (US), United States

Digital innovation GxP compliance QMS Biometrics Quality by design Quality Management Systems Industry Standards Transparency Employee stock purchase plan +65

Senior Full Time

USD 130K+

Product Operations Specialist
Remote-IL, United States

Centene Corporation

Grievances Operational performance Contact center Appeals Reporting tools Regulatory Affairs Claims Pharmacy Root Cause Analysis +33

USD 55K+

Sr. AD, Regulatory Excellence Team Lead (Remote)
Ridgefield, CT, United States, Connecticut

Boehringer Ingelheim

Capability development Cross-functional Leadership Regulatory Affairs Insights Influencing Governance Stakeholder engagement Stakeholder management Networking +10

Senior Full Time

USD 170K+

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 +13

Exec Senior Full Time

USD 176K+

Senior Manager, R&D Quality Operations & Excellence
Remote (US), United States

Risk-Based Quality Management ICH Requirements Internal Audits QMS Quality by design Inspection Readiness CAPA Employee stock purchase plan Audit Management +47

Senior Full Time

USD 130K+

Advisor/Senior Advisor - Regulatory Compliance and Post Market Reporting
US: USA Remote, United States

Eli Lilly and Company

Product Shortage Management Post Market Reporting Global Regulatory Reporting Inspection Readiness FDA regulations Volunteerism GMP Philanthropy Regulatory Affairs +21

Senior Full Time

USD 121K+

Regulatory Affairs Director - Global Regulatory Lead
US - Illinois - Chicago - Field/Remote, United States

Evidence-Based Communication Pediatric Plan Marketing Applications Clinical Trial Applications Global Regulatory Strategy Regulatory Strategies Regulatory expertise Global regulations Obesity +37

Senior Full Time

USD 197K+

Senior Director, Trade and Distribution
Remote (United States), United States

PTC Therapeutics, Inc.

Trade platform Distribution model configuration Specialty biologics Product distribution Distribution Strategy Operational Effectiveness Contracting Strategies Pharmacovigilance Patient services +16

Senior Full Time

USD 240K+

Senior Scientist, Research Science
USA - New Jersey - Rahway, United States

Biomarker assays Biofluids handling Clinical sample analysis Lab-based assay development Scientific oversight Biomarker Strategies Immunoassays Assay Development Drug development process +52

Senior Full Time

USD 104K+

Associate Director, Regulatory Labeling Strategy (Remote)
5000 - Vertex US - Boston, United States

Vertex Pharmaceuticals

Label Working Group Leadership Instruction for Use Development Regulatory labeling Labeling Strategy Cross-Functional Team Coordination Health Authority Interactions Regulatory Affairs People Management Research

Senior Mid Full Time

USD 161K+

Senior Regulatory Affairs Specialist
US Remote, United States

ISO 9000 GMP Compliance ISO Standards Medical Writing FDA regulations Neuromodulation Medical Technology Regulatory Submissions Healthcare systems +14

Senior Full Time

USD 115K+

Director of Communications, Issues Management and Crisis Mitigation (Hybrid - Rahway, NJ)
USA - New Jersey - Rahway, United States

Media analysis Crisis simulation Crisis communication Social Listening Pharmaceutical Industry Knowledge Issues management Communication Strategies Social Determinants of Health Simulation +37

Exec Senior Full Time

USD 169K+

Senior Director, Business Delivery Excellence (BDx)
US - CA - offsite, Estados Unidos

Gilead Sciences

Biomarkers Therapies Real-World Evidence Operational processes Strategic vision Drug Development Advanced Analytics Regulatory Affairs Clinical Development +28

Senior Full Time

USD 221K+

Director, Government & Regulatory Affairs
Remote

Digital health policies OMB review processes Budget policy Prescription drug regulation Federal reimbursement structures Regulatory engagement Healthcare Compliance Health IT Government Affairs +17

Exec Senior Full Time

USD 200K+

Remote Nursing Accreditation Specialist
Phoenix, AZ, United States

Unitek Learning

Healthcare Education Accreditation Adobe Acrobat Regulatory Affairs Leadership Development Regulations Auditing Nursing Microsoft Office +11

Entry Mid Full Time

USD 56K+

Senior Manufacturing Engineering Specialist
Canton, IL, United States

Medical device products Pneumatic components 3D CAD Automation Technologies HMI Sensors PLC Manufacturing processes Equipment Installation +9

Senior Full Time

USD 69K+

Sr. Regulatory Affairs Specialist (Andover, MA)
Andover, MA, United States

EU Technical Documentation 510k Submission Global Regulatory Strategies 510k Design control EU MDR Labeling Regulatory Submissions Standard Operating Procedures +8

Senior Mid Full Time

USD 126K+

Senior Director, Regulatory Affairs
Remote

Apogee Therapeutics

Antibody Engineering Global Regulatory Strategy Health Authority Interactions Document Preparation Regulatory Affairs Biotechnology Clinical trials R Regulatory Compliance +2

Senior Full Time

USD 250K+

Specialist, Quality Assurance - Hybrid
USA - New Jersey - Rahway, United States

Batch Documentation Deviations Investigational new drug applications MES Clinical supply chain Clinical Supply Current good manufacturing practices Regulatory Filing Clinical supplies +72

USD 85K+

Director, Technical Product Management – Quality &Regulatory
Remote, United States

TrackWise Pega Spotfire Budget Tracking Product quality SaaS solutions Strategy Development Regulatory Affairs Delivery +48

Exec Senior Full Time

USD 148K+

Sr. Medical Writer, Clinical Affairs
US - California - Southern - Remote, United States

Genomic NGS data Web-authoring tools Clinical protocols Genomic technology Sequencing Medical Writing Study Design Cultural Awareness Adobe Acrobat +19

Senior Full Time

USD 96K+

Business Analyst, Quality - Remote
USA - New Jersey - Rahway, United States

Device development Computer Programming Global Regulatory Affairs Clinical trial operations Clinical supply chain Oracle SQL Clinical Supply Spotfire Combination products +62

USD 104K+

Manager, Clinical Science/Medical Writing
USA-California-Remote, United States

Edwards Lifesciences

Clinical protocol development Clinical writing Clinical Affairs EU MDR Clinical study design Clinical Study Reports Literature review Clinical evaluation Protocol Development +25

Senior Full Time

USD 120K+

Labelling Strategist
US - California - Thousand Oaks - Field/Remote, United States

Global Regulatory Teams Health Authority Queries Core Labeling Documents Labeling Strategy Regulatory Strategies Obesity Labeling Strategic Guidance Pharmacology +47

Senior Full Time

USD 152K+

Medical Writer - Regulatory Submissions
US-Nationwide-FIELD, United States

Cardinal Health Remote-first

Scientific literature Data-driven summaries Regulatory Documents Medical Writing ISO 13485 Pay equity Document review Regulatory Submissions Regulatory Affairs +18

USD 93K+

Senior Director, Portfolio Management, Infectious Disease and Acute Care (IDAC)
USA - Remote, United States

Customer Needs Identification Diagnostic Solutions Innovation management Diagnostic Tools Sales and Marketing Biopharma Evidence Generation Regulatory Affairs Financial Acumen +28

Senior Full Time

USD 250K+

Senior Regulatory Affairs Specialist (Remote – United States)
Remote - Texas, United States

Solventum Remote-first

Medical Device Regulations Wound care Corporate policies Strategic growth ISO 13485 Data Tracking Materials Regulatory Affairs Branding +25

Senior Full Time

USD 137K+

Regulatory Affairs Manager (Remote – United States)
Remote - Texas, United States

Solventum Remote-first

Market Authorization Health Authority Interactions Medical Device Regulations Wound care Acquisitions Corporate policies Strategic growth ISO 13485 Strategy Development +28

Senior Full Time

USD 160K+

Executive Director, Head of Regulatory Affairs
Remote - US, United States

American Regent, Inc.

FDA Submissions CFR Compliance CMC Submissions Ectd format Regulatory strategy ICH Guidelines Veterinary Medicine Animal Health Regulatory Affairs +12

Exec Senior Full Time

USD 275K+

Sr Vice President & General Manager - Americas Region
US - California - San Diego - HQ, United States

Regional marketing Genomic technology Commercial operations Sequencing Commercial Strategy Cultural Awareness Talent Development Genomics Market development +20

Senior Full Time

USD 322K+

Sr. Medical Director, Clinical Development - Respiratory
Remote

Apogee Therapeutics

Antibody Engineering Medical Monitoring Study Design Pharmacovigilance Biostatistics Regulatory Affairs Biotechnology Clinical Development Team Management +3

Senior Full Time

USD 320K+

Associate Director, Data Management (Remote, US)
Jersey City, NJ, United States

Mitsubishi Tanabe Pharma

Electronic Data Capture Biostatistics Regulatory Affairs Clinical Development Oncology Data Management Quality Assurance Project Management

Senior Mid Full Time

USD 150K+

Compliance Analyst
Remote-IA, United States

Centene Corporation

Regulatory Interpretation Regulatory filings Compliance monitoring Training Programs Risk assessments Regulatory Affairs Procedures Policy Development Audits +18

Entry Mid Full Time

USD 55K+

Senior Specialist, Regulatory Affairs - Remote
Westborough, MA, US, 01581

Olympus Corporation of the Americas

Regulatory Affairs Process Development Regulatory requirements Medical device Change Management R Quality Assurance Regulatory Compliance Mentoring +7

Senior Full Time

USD 86K+

Senior Director, NM Project Head
US Remote, United States

Medical Technology Healthcare systems Cross-functional Leadership Regulatory Affairs Resource Allocation GDPR Product Design Medical device HIPAA +15

Senior Full Time

USD 200K+

Senior, Regulatory Specialist
USA-PA Remote, United States

Validations Impurities analysis Cares Ich q7 Ipec Compendial compliance Ectd format Gdufa 21 CFR 210 +19

Senior Full Time

USD 75K+

Distinguished Scientist, Clinical Research, Thoracic Oncology
USA - New Jersey - Rahway, United States

Regulatory Approval Clinical Trials Design Biomedical Research Clinical Development Strategies Investigational new drug applications Clinical Medicine Early clinical development Translational Research Research Methodologies +56

Exec Senior Full Time

USD 304K+

Director of Public Healthcare and Payor Compliance
United States - Remote

Kestra Medical Technologies, Inc

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

Exec Senior Full Time

USD 185K+

Senior Director, Compliance Advisory (Marketplace)
Remote-MO, United States

Centene Corporation

ACA requirements Executive Reporting Audit readiness Government programs Health Plan Compliance requirements Metrics Development Health administration Healthcare Regulations +36

Senior Full Time

USD 145K+

Sr Regulatory Affairs Specialist (Remote)
USA-CA Northridge, United States

Digital Health Apps Change Notifications Engineering Change Requests Submission Preparation Global Regulatory Strategies Regulatory Documentation Medical Device Regulations ISO 14971 Labeling +36

Senior Full Time

USD 133K+

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