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Regulatory Affairs Remote Jobs

56 fresh jobs found

Intern, Regulatory Affairs
United States Remote Office, United States

Regulatory Affairs Regulatory Written communication PowerPoint Word Microsoft Office Excel Healthcare Leadership +1

Entry Internship Full Time

USD 40K+

Clinical Director, Oncology Early Development
USA - New Jersey - Rahway, United States

External partnerships Clinical Medicine Biomedical Research Scientific Writing Publication Scientific research Research Methodologies Animal Health Products Research Experience +52

Exec Senior Full Time

USD 243K+

Senior Clinical Evaluation Medical Writer - CRDN
USA-MN, United States

Clinical evaluation Medical Device Regulations Clinical evidence Data Extraction Medical Writing Healthcare Access MS Project Medical Technology Regulatory Submissions +31

Senior Full Time

USD 154K+

Principal Scientist, Clinical Research, GYN Malignancies
USA - New Jersey - Rahway, United States

Clinical Medicine Clinical Development Strategies Investigational new drug applications Early clinical development Clinical Trials Design Biomedical Research Publication Research Methodologies Animal Health Products +43

Senior Full Time

USD 250K+

Emerging Regulations Specialist (Solventum)
Remote - Minnesota, United States

Solventum Remote-first

Hazard communication EU legislation Chemical controls Product stewardship Toxicology Consumer Products Life Science Regulatory Affairs Branding +17

Senior Full Time

USD 160K+

Principal Scientist/Director, Regulatory Affairs-CMC (Chemistry, Manufacturing & Controls)
USA - New Jersey - Rahway, United States

Drug-Device Combinations NDA Chemical MAA CTA BLA Design control Health authorities Acquisitions +55

Senior Full Time

USD 181K+

Director, Market Access and Medical Policy, Genetic Testing
USA - NC - Burlington - 348 S Main Street, United States

Medical policy Clinical utility Health plan negotiations Payer messaging Commercial payer strategy Publication strategy Payer strategy Genetic Testing Value-based care +19

Exec Senior Full Time

USD 170K+

Assoc Dir Global Regulatory Affairs
Remote, United States

Otsuka Pharmaceutical Companies

RIMS EDMS Labeling Impactful Communication Pharmaceutical Development Negotiations Regulatory Affairs XML Oral communication +18

Senior Full Time

USD 183K+

Senior Medical Information Specialist
Remote, REMOTE, United States

Guardant Health

Pharmaceutical products Medical Writing Marketing Support Medical Strategy Clinical Data Pharmacovigilance Medical Information Medical science Regulatory Affairs +26

Senior Full Time

USD 107K+

Associate Director, GPS Standards & Training
Remote - United States, United States

BPTs WIs Inspection Readiness Drug Safety CAPA Metrics analysis Pharmacovigilance SOPS Regulatory Affairs +8

Senior Mid Full Time

USD 154K+

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

Safety Leadership Global Regulatory Affairs Process Performance Impact assessment Clinical Safety Inspections Process Control Business Process Management Methodology +60

Senior Full Time

USD 169K+

Senior Medical Director, Hematology
Remote (US), United States

Medical Support Drug development process Clinical study design Clinical Study Reports Biometrics Translational Research Budget planning Medical Writing Scientific Expertise +45

Senior Full Time

USD 280K+

Executive Director, Regulatory Affairs - Cell Medicine
Remote - United States, United States

NDA CTA BLA Gene therapy IND CMC Cell Therapy Biologics Regulatory Submissions +12

Exec Senior Full Time

USD 251K+

Associate Medical Director - Neuropsychiatry (US Medical Affairs)
Remote, REMOTE, United States

Regulatory Review Neuropsychiatry Medical Director Regulatory Guidelines Regulatory Affairs Medical Affairs Pharmaceutical Industry Biotechnology Presentation +4

USD 162K+

Senior Manager, GCP Inspection Management
Remote (US), United States

ICH Requirements Clinical Study Review Inspection Readiness Clinical Study Reports Biometrics FDA regulations SOP Development Protocols Pharmacovigilance +45

Senior Full Time

USD 127K+

Sr. AD, Medicine Capability Process Excellence (Remote)
Ridgefield, CT, United States, Connecticut

Boehringer Ingelheim

Process excellence Segmentation Regulatory Affairs Medical Affairs Clinical Development Agile Methodology Performance Metrics Stakeholder engagement Change Management +7

Senior Full Time

USD 170K+

Lead User Researcher, Business Borrowing
Cardiff, London or Remote (UK)

Diary Studies Tree-Tests Card-Sorts Field Observations Concept Testing Usability studies Core banking Statistical Concepts Interviews +25

Senior Full Time

GBP 110K+

Senior Manager, Regulatory Affairs Americas
US - Morristown, NJ, United States

Regulatory intelligence Regulatory Affairs R&D Regulatory requirements Life sciences Creativity Customer Support Regulatory Compliance Product Management +11

Senior Full Time

USD 161K+

Director, Diagnostics Lead
Remote (US), United States

Biomarker testing Companion diagnostics Regulatory Documents Regulatory Affairs Financial excellence Clinical Development Entrepreneurial Mindset Regulatory requirements Office +24

Senior Full Time

USD 175K+

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

Regulatory Filing Clinical Development Strategies Investigational new drug applications Clinical Medicine Early clinical development Clinical Trials Design Scientific Writing Publication Collaborative relationships +40

Exec Senior Full Time

USD 304K+

Senior Director, Regulatory Affairs
Remote (WFH)

Adaptive Biotechnologies

Global Regulatory Strategy FDA compliance Next-Generation Sequencing Commercialization Immunology Regulatory Affairs Clinical Development Hematology Market Access +14

Senior Full Time

USD 204K+

Regulatory Affairs Coordinator (EU)
Remote

EU regulations Regulatory Affairs Translation Google Sheets Database Management Stakeholder engagement Attention to detail Research Interpersonal +3

GBP 26K+

Director, Clinical Science
Remote (US), United States

Medical Support Clinical study design Drug development process Scientific Writing Clinical Study Reports Biometrics Translational Research Budget planning ICH Guidelines +51

Exec Senior Full Time

USD 171K+

Specialist, Global Regulatory Affairs (GRA) Brands Chemistry, Manufacturing & Controls (CMC)
United States Remote Office, United States

Documentum CTD CMC ICH Regulatory Submissions Regulatory Affairs Controls Oral communication Chemistry +17

Entry Senior Full Time

USD 41K+

Administrative Coordinator - Compliance - Day Shift - Full Time
Health Plan-Telecommuter, United States

Sharp HealthCare

Office Equipment Use Legal Interpretation Administrative coordination Filing Record keeping Project Coordination Regulatory Affairs Confidentiality Time Management +4

USD 29K+

Cloud Security Engineer
Remote, USA, United States

Cloud Control Frameworks CSA CCM Technology risk compliance Training program design Control testing Risk Management Framework Security Controls Process Mapping Internal Audit +23

Senior Full Time

USD 136K+

Director, Global Market Access (CNS) (Remote)
Remote, United States

Otsuka Pharmaceutical Companies

Global Market Access Payer Insights CNS Reimbursement strategy Market Access Strategies Value proposition development Clinical Strategy Pharmaceutical products Impactful Communication +28

Exec Senior Full Time

USD 179K+

Compliance Analyst - Managed Care
Remote-OK, United States

Centene Corporation

Legislation monitoring Regulatory Affairs Database Management Policy Development Auditing Managed Care Regulatory Risk Assessment HIPAA +3

Entry Mid Full Time

USD 54K+

Global Regulatory Policy and Intelligence Director
US - California - Thousand Oaks - Field/Remote, United States

Regulatory intelligence Health authorities Regulatory policy Regulatory Analysis Policy Advocacy Biopharmaceutical Industry Strategic advice Real-world data Biopharmaceutical +30

Exec Senior Mid Full Time

USD 167K+

Senior Regulatory Affairs Specialist
Tennessee, Virtual Address, United States

Marketing compliance Stakeholder training Regulatory intelligence Marketing materials Labeling Product Lifecycle Regulatory strategy Regulatory Submissions Functions +14

Senior Mid Full Time

USD 75K+

Senior Compliance Analyst
Remote-KS, United States

Centene Corporation

Regulatory Affairs Policy Development Auditing Regulatory Risk Assessment HIPAA Monitoring Education Documentation +3

Senior Mid Full Time

USD 67K+

Distinguished Scientist, Product Development Team Leader, Clinical Research, Breast Cancer
USA - New Jersey - Rahway, United States

Breast cancer Publication Regulatory Approval Clinical Medicine Biomedical Research Investigational new drug applications Clinical Trials Design Clinical Development Strategies Scientific Leadership +56

Senior Full Time

USD 295K+

Senior Director Clinical Development, Lung Franchise
Remote (US), United States

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

Senior Full Time

USD 280K+

Product Manager, Subscriptions Partnerships
Remote (UK)

Roadmap Prioritization Partnership Management Financial Education Interviews Resilience Financial products Regulatory Affairs Market strategy Experimentation +15

GBP 85K+

Engagement Manager - Life Sciences R&D
Massachusetts - Boston

Veeva Systems Remote-first

Pharmaceutical R&D Emerging tech Emerging technology Drug Safety Consulting Services Digital Technologies SaaS solutions Pharmacovigilance Analytics tools +23

Senior Full Time

USD 85K+

VP, Deputy General Counsel
New York, NY; Remote, US

Reproductive Health Fertility Corporate governance Regulatory Affairs Digital Health Email Risk mitigation Data privacy Fintech +9

Exec Senior Full Time

USD 290K+

Senior Counsel II, U.S. Antitrust
US - NC - offsite, Estados Unidos

Gilead Sciences

Antitrust law Commercial Agreements Intellectual property Creative Problem Solving Regulatory Affairs Therapies Supply chain management Litigation Vision +15

Senior Full Time

USD 216K+

Distinguished Scientist, Product Development Team Leader, Clinical Research, Melanoma
USA - New Jersey - Rahway, United States

Breast cancer Publication Regulatory Approval Clinical Medicine Investigational new drug applications Biomedical Research Clinical Trials Design Clinical Development Strategies Scientific Leadership +56

Senior Full Time

USD 295K+

Director, Regulatory Affairs - CMC
Remote - United States, United States

Bristol Myers Squibb

NDA DMF MAA Health Authority Responses Quality Module CTA Radiopharmaceuticals IND Analytical Methods +16

Exec Senior Full Time

USD 204K+

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+

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+

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+

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+

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+

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 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 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+

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+

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+

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