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Regulatory Submissions Remote Jobs

99 fresh jobs found

Senior Director, Biostatistics
United States - Remote

Statistical Methodologies Clinical programs ICH Guidelines Publications Biostatistics Regulatory Submissions Clinical Development Statistical analysis Reimbursement +6

Senior Full Time

USD 245K+

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+

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+

Start Up Lead
Remote, United States

Precision for Medicine

Site start-up Critical path planning Budget negotiation ICH Guidelines Documentation Management ICH Precision Medicine Regulatory Submissions Clinical operations +19

Senior Mid Full Time

USD 106K+

Start Up Lead
Remote, United States

Precision Medicine Group

Site start-up Critical path planning Budget negotiation Contracts Management Good Clinical Practice ICH Guidelines Documentation Management ICH Precision Medicine +23

Senior Full Time

USD 106K+

Executive Director Clinical Scientist
Remote, Boston MA

Target/pathway engagement assays Clinical study protocol development Translational Medicine Literature reviews Biomarkers Clinical Pharmacology Data Review Biostatistics Regulatory Submissions +5

Exec Senior Full Time

USD 270K+

Medical Safety Director
United States of America - Home Based

Clinical evaluation reports Clinical risk assessment Safety studies Medical device vigilance Post-marketing surveillance Health hazard evaluations Risk-benefit analyses Medical safety Literature reviews +28

Exec Mid Full Time

USD 156K+

Associate Director, Manufacturing Science and Technology
Remote

Apogee Therapeutics

Monoclonal Antibody Manufacturing science Tech Transfer Process Characterization Purification Cell Culture Antibody Engineering GMP Biologics +10

Senior Mid Full Time

USD 160K+

Associate Director/Director, Biostatistician
Boston, San Diego, Remote

Sample Size Estimation Data standardization Statistical Methodology Clinical Study Reports Statistical Programming Drug Discovery Study Design Data Validation Biostatistics +10

Senior Mid Full Time

USD 180K+

Senior Medical Director, Pharmacovigilance, Gastrointestinal and Inflammation (Remote)
USA - MA - Virtual, United States

Safety Monitoring Medical safety Safety Assessment Signal detection Patient Safety Pharmacovigilance Regulatory Submissions Drug Development Clinical Development +23

Senior Full Time

USD 256K+

Observational Research Manager
US - California - Thousand Oaks - Field/Remote, United States

Research Support Scientific Writing Obesity Observational Research Literature review Epidemiology Pharmacovigilance Publications Commercialization +29

USD 113K+

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+

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 Medical Director, Global Medical Safety (Oncology) - Remote US
USA - MA - Virtual, United States

Safety strategy Benefit-risk assessment Safety Monitoring Medical safety Safety Assessment Signal detection Patient Safety Pharmacovigilance Regulatory Submissions +20

Senior Full Time

USD 256K+

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+

Associate Director, Safety Scientist
Cambridge, MA, United States

Sarepta Therapeutics

Safety reporting Gene editing RNA Signal detection Gene therapy Medical Review Pharmacovigilance ICH Regulatory Submissions +9

USD 156K+

Principal Biostatistician
USA-Maryland-Remote, United States

Edwards Lifesciences

Clinical database development Medical device research Clinical Affairs Data Quality Assurance Regulatory Guidelines Statistical methods ICH Biostatistics Statistical modeling +32

Senior Mid Full Time

USD 129K+

QA Manager, DP Commercial Small Molecule
Remote (US), United States

Small Molecule Quality Risk Management Cross-Department Collaboration CMC CGMP Good Manufacturing Practices Quality Systems Audit Management Incentive Compensation +38

USD 104K+

Clinical Research Medical Director - Hematology Oncology
US - Maryland - Baltimore -Field/Remote, United States

EMEA guidelines Pharmaceutical Product Development International regulatory requirements Basic Science Research Lung cancer Regulatory Interactions Medical Monitoring Observational Research Patient reported outcomes +46

Exec Mid Full Time

USD 261K+

Executive Director, Biologics Drug Substance Commercialization
USA - Pennsylvania - West Point, United States

Drug substance commercialization Expression QbD Process Characterization Capital Projects Biologic BLA Development and commercialization Large Molecule +53

Exec Senior Full Time

USD 227K+

Director, Clinical Pharmacology ( UK or US Remote )
US - Home-Based - MD, United States

Jazz Pharmaceuticals

Population pk Phoenix WinNonlin PK/PD ADAPT Nonmem Clinical Pharmacology Incentive Compensation Cross-functional Teamwork Neuroscience +7

Exec Senior Full Time

USD 188K+

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+

Senior Advisor - CRS
US: USA Remote, United States

Eli Lilly and Company

Scientific analysis Research Experience Scientific Knowledge Good clinical practices Pharmacology Volunteerism Pharmacovigilance Philanthropy Document management +30

Senior Full Time

USD 142K+

Associate Director - Patent Research - IP Litigation
US: USA Remote, United States

Eli Lilly and Company

IP Litigation Patent Research Artificial Intelligence Tools Regulatory Analysis Litigation Support Drug Discovery Technical Analysis Volunteerism Philanthropy +20

USD 122K+

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+

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+

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+

Clinical Research Medical Director, T2D, US - Remote
US - California - Thousand Oaks - Field/Remote, United States

Clinical Teaching Metabolic Pharmaceutical Product Development International regulatory requirements Basic Science Research Clinical Study Reports Regulatory Interactions Observational Research Patient reported outcomes +52

Exec Mid Full Time

USD 261K+

Senior Principal Pharmacovigilance Scientist in Inflammation
USA - MA - Virtual, United States

Aggregate Safety Reports Case Report QC Safety Monitoring Medical safety Signal detection Patient Safety Community outreach Pharmacovigilance Regulatory Submissions +19

Senior Full Time

USD 133K+

Sr. Regulatory Document Formatting Specialist
San Carlos, California

Document Templates Document Assembly Veeva RIM Document Formatting Adobe Acrobat Pro Regulatory Submissions Veeva Microsoft Word PowerPoint +6

Senior Full Time

USD 122K+

Medical Sciences Director- Late Development Oncology, Prostate
US - California - Thousand Oaks - Field/Remote, United States

Clinical Data Review Translational Research Regulatory Interactions Clinical trial data Spotfire Data Review Insight Experimental Design Clinical Practice +39

Exec Senior Mid Full Time

USD 211K+

Associate Director, Medical Writing
Cambridge, MA, United States

Sarepta Therapeutics

Gene editing RNA Scientific Writing Gene therapy SOP Development Medical Writing ICH Regulatory Submissions Clinical Documentation +7

USD 156K+

Associate Director, Analytical Chemistry
Remote Worker

Stability studies Control strategies Analytical reference standards Method optimization Technical investigations Method development Analytical Chemistry Characterization ICH +9

Senior Mid Full Time

USD 165K+

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+

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+

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 - Biostatistics
Remote - United States, United States

Bristol Myers Squibb

Cardiovascular disease Statistical Methodology Cell Therapy Protocol Development Study Design Regulatory Submissions Immunology Biostatistics Hematology +18

USD 189K+

Sr. Medical Science Writer - Remote
USA-MN Rice Creek East, United States

Scientific Manuscript Development Abstract Development Clinical Data Interpretation Literature Searches Clinical evidence Clinical evaluation Healthcare Access Healthcare Solutions Metrics Tracking +23

Senior Mid Full Time

USD 154K+

Senior Director, Formulation and Drug Product Development
Remote

Apogee Therapeutics

Stability data analysis Drug product supply Clinical studies support QbD approach Aseptic manufacturing Protein drug product development Formulation Development Antibody Engineering Quality Compliance +17

Senior Full Time

USD 235K+

Medical Safety Director
United States of America - Remote Based

Clinical risk assessment Medical device vigilance Safety studies Clinical evaluation reports Post-marketing surveillance Health hazard evaluations Risk-benefit analyses Medical safety Literature reviews +28

Exec Mid Full Time

USD 156K+

Analysis Oversight Statistical Programming Lead- Manager
US - CA - Bay Area - offsite, Estados Unidos

Gilead Sciences

Clinical Trial Programming Programming Outputs CDISC ICH Guidelines Analytical Methods Statistical Programming Therapies Regulatory Submissions Biostatistics +25

Senior Mid Full Time

USD 146K+

Analysis Oversight Statistical Programming- Senior Manager
US - CA - Bay Area - offsite, Estados Unidos

Gilead Sciences

Clinical Trial Programming Programming Outputs CDISC ICH Guidelines Analytical Methods Statistical Programming Therapies Regulatory Submissions Biostatistics +25

Senior Full Time

USD 169K+

Senior Biostatistician / Data Scientist
San Francisco, Remote

PicnicHealth Remote-first

Sample Size Analysis Observational studies Patient reported outcomes Observational Research Real-world data Analytical Methods Protocol Development Epidemiology Study Design +26

Senior Full Time

USD 150K+

Senior Medical Scientist, Global Medical Affairs, Cardiovascular
US - California - Thousand Oaks - Field/Remote, United States

Medical Communication Pharmaceutical Product Development Ethical conduct ADAPT Data Dissemination Medical Knowledge KOL Engagement Product Lifecycle Product lifecycle management +57

Senior Full Time

USD 168K+

Medical Sciences Director - Late Development Obesity and Endocrinology Diseases, US - Remote
US - California - Thousand Oaks - Field/Remote, United States

Translational science Data quality assessment Clinical Data Review Metabolic Regulatory Interactions Obesity Metabolic diseases Clinical trial data Spotfire +45

Exec Senior Full Time

USD 211K+

Director, Biostatistics
Remote

Apogee Therapeutics

Sample size determination Adaptive designs Statistical integrity Bayesian Methods Antibody Engineering SDTM ADaM Data Monitoring CDISC +14

Exec Senior Full Time

USD 225K+

Clinical Research Medical Director, Endocrinology/Obesity - US Remote
US - California - Thousand Oaks - Field/Remote, United States

Clinical Teaching Metabolic Pharmaceutical Product Development International regulatory requirements Basic Science Research Regulatory Interactions Clinical Study Reports Patient reported outcomes Obesity +47

Exec Mid Full Time

USD 261K+

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