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Regulatory Affairs Remote Jobs

87 fresh jobs found

Senior Director, GMP and GLP Quality Assurance
New York, New York, United States; Remote, United States

HIV GLP Quality Management System GMP Biologics Vaccines Regulatory Affairs Public health Product Development +9

Senior Full Time

USD 180K+

Medical Science Liaison Biosimilars – South Central U.S.
Lake Zurich Remote (Pharma), United States

Scientific Document Writing Biosimilars Clinical applications Scientific Exchange Medical Science Liaison Scientific communication Regulatory Affairs Immunology Pharmaceutical Industry +3

USD 140K+

Medical Science Liaison Biosimilars – North Central U.S.
Lake Zurich Remote (Pharma), United States

Biosimilars Data Generation Clinical applications Regulatory Guidelines Scientific Exchange Medical Science Liaison Scientific communication Regulatory Affairs Immunology +7

USD 140K+

Director, Clinical Development, Solid Tumor
Remote (US), United States

Medical Support Drug development process Clinical study design Clinical Study Reports Biometrics Translational Research Budget planning ICH Guidelines Competitor Analysis +45

Exec Senior Full Time

USD 232K+

Vice President, DCTL, Sonrotoclax
Remote (US), United States

Medical Support Drug development process Clinical study design Clinical Study Reports Biometrics Translational Research Budget planning ICH Guidelines Competitor Analysis +42

Exec Senior Full Time

USD 339K+

Sr. Manager, Statistical Programming
US - OH - offsite, Estados Unidos

Gilead Sciences

Programming Deliverables Clinical Data Science Statistical Data Analysis Efficacy Validation Efficacy Analysis Data Standards Clinical Trials Design Statistical Programming Regulatory reporting +20

Senior Full Time

USD 150K+

Product Director, App Experience
Cardiff, London or Remote (UK)

Metrics Definition Core banking Platform Financial Education Interviews Resilience Personalization Cross-functional Teamwork Financial products +18

Exec Senior Full Time

GBP 120K+

Senior Principal Scientist, Regulatory Liaison (Sr. Director, GRL)
USA - New Jersey - Rahway

FDA Communication Global Regulatory Affairs Clinical Safety Global Regulatory Strategy IND Large Molecule Neuroscience Formulation Ophthalmology +34

Senior Full Time

USD 181K+

Senior Associate, Medical Writing Business Operations
US - CA - offsite

Gilead Sciences

Scientific review Virology Medical Writing Regulatory Submissions Therapies Regulatory Affairs Drug Development Diversity and Inclusion Vision +18

Senior Mid Full Time

USD 104K+

Senior Credit Modeling & Analytics Manager
Remote, USA

Agile Modeling Back Testing Behavioral Modeling Liquidity risk Risk analytics Econometric Modeling Interest rate risk Quantitative Modeling Verbal +40

Senior Full Time

USD 161K+

Senior Specialist, Regulatory Affairs - VIP/ADI (Remote)
NAPLES, FL, US, 34108

Engineering Change Requests Health Canada FDA Submissions Medical Device Regulations EU MDR Orthopedics Design control Risk Evaluation Labeling +9

Senior Full Time

USD 90K+

Senior Clinical Evaluation Specialist (Remote)
Massachusetts, Boston Virtual Address

Clinical evaluation Systematic Reviews Clinical Strategy New Product Development Medical Writing Regulatory strategy Clinical Documentation M Regulatory Affairs +24

Senior Mid Full Time

USD 75K+

Sr Regulatory Affairs Specialist
Remote California

IEC Standards FDA guidance AI/ML technologies ISO Standards Algorithm Development Continuous Glucose Monitoring Health Technology Mobile applications ISO +24

Senior Full Time

USD 87K+

Senior Medical Director, Global Medical Strategy Franchise Lead- Rare Disease
Remote

Otsuka Pharmaceutical Companies

Healthcare Landscape Medical Review Impactful Communication Regulatory knowledge Evidence Generation Pharmaceutical Development Real-World Evidence Strategic Leadership Regulatory Affairs +19

Senior Full Time

USD 225K+

Director Global Oncology Marketing Gastrointestinal (GI) Cancers
USA - New Jersey - Rahway

Disease state strategy Competitive strategy Health Authority Interactions Launch strategy Market Assessment Oncology marketing Issues management Regulatory Filing Scientific Communications +52

Exec Senior Full Time

USD 181K+

Clinical Research Medical Director, Rare Disease- Rheumatology/Immunology
US - California - Thousand Oaks - Field/Remote

Key Opinion Leader Development Basic Science Research Global Strategy Clinical trial data Regulatory Interactions Product Lifecycle Scientific Knowledge Biopharmaceutical Industry Clinical Trial Management +35

Exec Senior Mid Full Time

USD 256K+

Senior Manager, Veterinary Medicine.
Remote - US

American Regent, Inc.

FDA-CVM regulations Pre-clinical studies Investigator meetings Medical Review Biometrics Veterinary Medicine Medical Writing Therapeutic Area Expertise Pharmacovigilance +13

Senior Full Time

USD 140K+

Director, Clinical Research, Cardiovascular and Respiratory
USA - New Jersey - Rahway

Clinical Medicine Clinical Trials Design Investigational new drug applications Clinical Development Strategies Biomedical Research Scientific Knowledge Early clinical development Research Experience Research Methodologies +40

Exec Mid Full Time

USD 243K+

Sr. Director, Drug/Device Combination Products, Process Integration and Tech Transfer
USA - Pennsylvania - West Point

Technical transfer Combination product development Manufacturing readiness Device risk management Human factors Clinical Safety Analytical Method Development Design Controls Mechanical systems +67

Senior Full Time

USD 164K+

Director, Global Regulatory Affairs & Clinical Safety (GRACS), Global Process Lead
USA - New Jersey - Rahway

Impact assessment Global Regulatory Affairs Clinical Safety Process Performance Inspections Process Control Business Process Management Learning & Development M&A +61

Senior Full Time

USD 164K+

Associate Director, Global Regulatory Lead
Remote (US)

CTA Submission documentation Global regulatory environment Global Regulatory Requirements Marketing Approval Health Authority Interactions Drug development process Global Regulatory Strategy BLA +41

Senior Mid Full Time

USD 142K+

Principal Data Scientist, Real World Evidence - REMOTE
Remote Opportunity

Propensity Score Models Monte Carlo Simulations Regression modeling Data Quality Management Statistical Programming Causal inference Statistical modeling Biostatistics Regulatory Affairs +13

Senior Full Time

USD 224K+

Director, Global Regulatory Strategist (Eye Care)
United States Remote Office

Health Authority Interaction Documentation preparation Global regulations Regulatory strategy Due Diligence Quality Standards Regulatory Affairs Drug Development Clinical Development +16

Exec Senior Full Time

USD 112K+

Senior Regulatory Specialist
Lake Zurich Remote (Pharma)

Persuasive Communication Submission Preparation CGMP ICH Guidelines FDA Regulatory Affairs Quality Assurance Mentoring Training

Senior Mid Full Time

USD 103K+

Director, Global CMC Strategy (Eye Care)
United States Remote Office

CMC strategy Health Authority Engagement Technical Services Pharmaceuticals Due Diligence Quality Standards Regulatory Affairs Drug Development Risk mitigation +19

Exec Senior Full Time

USD 112K+

Regulatory Remediation Manager
Remote, USA

Remediation strategies Regulatory agency communication Process execution Documentation preparation Regulatory knowledge Guidance Regulatory standards Regulatory Affairs Stakeholder communication +11

USD 85K+

State Regulatory Specialist - Crop Nutrition
Loveland, CO, US, 80538

Agricultural science Crop nutrition State registrations Label reviews Fertilizer Crop protection Agriculture Regulatory Affairs Database Management +9

USD 59K+

Manager, North America Regulatory - Crop Nutrition
Loveland, CO, US, 80538

Agriculture regulations EPA compliance Crop nutrition Label review Fertilizer Agronomy Agriculture Training and Development Regulatory Affairs +12

Senior Full Time

USD 95K+

Regulatory Specialist - Crop Protection
Loveland, CO, US, 80538

Label review Crop protection Agronomy Agriculture Cross-functional Teamwork Regulatory Submissions Stakeholder Collaboration Regulatory Affairs R&D +10

USD 59K+

Territory Manager, MCS - Charlotte, NC
United States of America : Remote

Reimbursement Policies Account Assessment Training & Education Research & Development Concur Expense Management Heart failure Training and education Strategic Selling +37

USD 76K+

Director, Clinical Trial Diversity, Clinical Operations
Remote (US)

Clinical Study Protocols Diversity Strategy Patient Recruitment Clinical Trial Management Health Equity Protocols Entrepreneurial Mindset Financial excellence Clinical operations +41

Exec Senior Full Time

USD 159K+

Vice President, R&D Finance
Remote (US)

Bio-pharma knowledge Treasury Business Partnering ROI Patient Safety Entrepreneurial Mindset Financial excellence Automation tools FP&A +40

Exec Senior Full Time

USD 298K+

Learning Management System (LMS) Administrator
Remote, USA, United States

LMS administration SuccessFactors Biometrics GxP Regulatory Affairs ServiceNow Biotechnology Medical Affairs Case Management +10

USD 57K+

Sr. Medical Director, Clinical Development
Remote - United States

Bristol Myers Squibb

Radiopharmaceuticals Regulatory Documents Medical Monitoring ICH Guidelines Cell Therapy Pharmaceuticals Regulatory Affairs Clinical knowledge Clinical Development +13

Exec Senior Full Time

USD 297K+

Senior Manager, Submissions Operations Management
Remote (US)

Submission publishing Dossier execution Ectd experience Document formatting Submission Management ECTD Industry Standards Regulatory operations Training and Mentoring +32

Senior Full Time

USD 132K+

Manager, Submission Operations Management
Remote (US)

Submission Management ECTD Regulatory operations Document review Regulatory Guidelines Entrepreneurial Mindset Financial excellence Regulatory Submissions Regulatory Affairs +19

Senior Mid Full Time

USD 108K+

Regulatory Affairs Senior Manager – Regional Regulatory Lead
US - California - Thousand Oaks - Field/Remote

Clinical trial authorization Marketing application approval Regulatory intelligence Regulatory policy Clinical trial authorizations Regulatory research FDA Interactions Regulatory Strategies Global Regulatory Strategy +28

Senior Mid Full Time

USD 139K+

Senior Specialist - Enterprise Data Governance Risk Support
Remote, USA

Technology risk compliance Training program design Risk Management Framework Process Mapping Internal Audit Risk Analysis Regulatory standards Guidance Regulatory Affairs +19

Senior Full Time

USD 115K+

Director of Medical Affairs
Remote - US

American Regent, Inc.

Regulatory Review Scientific Advisory HEOR Medical Strategy Regulatory Affairs Clinical Development Statistical analysis Medical Affairs Clinical Research +7

Exec Senior Full Time

USD 183K+

Regulatory Affairs Manager
Ireland

Financial Education Regulatory Affairs Diversity and Inclusion Banking Artificial Intelligence Governance Financial Services Stakeholder engagement Verbal communication +9

GBP 84K+

Associate Director, Global Regulatory Process and Compliance
Remote (US)

Metrics establishment Internal Audits Information Governance Audit Support Training Coordination Inspection Readiness KPI Monitoring Entrepreneurial Mindset Financial excellence +35

Senior Mid Full Time

USD 142K+

Senior Regulatory Affairs Specialist (USA - Remote)
USA - Remote

International registrations Clinical evaluations Medical Device Submissions 510k ISO 13485 SOPS Regulatory Affairs Medical device Human Resources +12

Senior Mid Full Time

USD 83K+

Principal Regulatory Affairs Specialist
Remote worker located in the USA

Digital Health Software AI/ML in Medical Devices Medical Device Submissions SOP Development Regulatory Affairs Deep Learning Technical Documentation Cross-functional Collaboration Project Management

Senior Full Time

USD 125K+

Executive Director, Global Regulatory Affairs Companion Diagnostics
Remote (US)

Health Authority Engagement Global Regulatory Requirements People development Health Authority Interactions Regulatory Documents Regulatory strategy Entrepreneurial Mindset Regulatory Guidelines Financial excellence +36

Exec Senior Full Time

USD 212K+

Director Alliance Management
US-CA-Remote Location

Agilent Technologies

Companion diagnostics Diagnostic products Alliance Management Biopharma Pharma Biopharmaceutical Precision Medicine Commercialization Regulatory Affairs +17

Exec Senior Full Time

USD 102K+

Regulatory Affairs Senior Manager – Regional Regulatory Lead
US - Indiana - Indianapolis - Field/Remote

Clinical trial authorizations Regulatory intelligence Regulatory policy FDA Interactions Regulatory research Regulatory Strategies Marketing Applications Global Regulatory Strategy Regulatory Documents +25

Senior Mid Full Time

USD 139K+

Senior Manager, Regulatory Affairs
US Remote

Obstructive Sleep Apnea Quality Systems Motivational Clinical Trial Design Neuromodulation Medical Technology Healthcare systems Regulatory Submissions Regulatory Affairs +14

Senior Full Time

USD 120K+

Executive Director, Statistical Programming (Hybrid)
USA - Pennsylvania - North Wales (Upper Gwynedd)

Advanced programming techniques Analysis software Clinical Safety Reporting processes Translational Medicine Research decision sciences PK/PD Regulatory Approval Biomarkers +59

Exec Senior Full Time

USD 220K+

Sr. Scientist, Regulatory Affairs & Product Development (Non-Clinical Submissions)
US-Nationwide-FIELD

Cardinal Health

Submission documentation Nonclinical submissions Clinical Submissions Regulatory Strategies Clinical trial applications Data verification Regulatory Documents Global regulations Regulatory Guidance +16

Senior Full Time

USD 121K+

Senior Director, Clinical Research, Metabolism
USA - New Jersey - Rahway

Metabolic disorders Metabolism Clinical Medicine Investigational new drug applications Clinical Trials Design Clinical Development Strategies Biomedical Research Early clinical development Research Experience +45

Senior Full Time

USD 268K+

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