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Regulatory Submissions Remote Jobs

61 fresh jobs found

Senior Medical Director
Remote Opportunity

Research initiatives Clinical Pharmacology Clinical Trial Design Regulatory Submissions Drug Development Clinical Development Biotechnology Clinical trials Oncology +2

Senior Full Time

USD 250K+

Medical Director
Remote Opportunity

Research initiatives Research Programs Clinical Pharmacology Clinical Trial Design Regulatory Submissions Drug Development Clinical Development Biotechnology Clinical trials +3

Exec Mid Full Time

USD 234K+

Senior Biostatistician FSP, Late Phase
Durham, North Carolina, United States of America

Inferential analyses Simulations Biomarker analyses Multivariate analyses Exploratory analyses CDASH Clinical trial protocols Statistical analysis plans SDTM +27

Senior Full Time

USD 115K+

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+

Associate Medical Director, Clinical Development
Remote, REMOTE, United States

Regulatory Documents Regulatory Interactions Biomarkers Medical Director Clinical Trial Design Biostatistics Regulatory Submissions Clinical operations Clinical Development +9

USD 161K+

Lead Biostatistician
US Remote

Probability Theory Applied Statistics Statistical Concepts Statistical Methodology Cell-free DNA Orientation Collection Protocols Clinical Trial Design +29

Senior Mid Full Time

USD 126K+

Senior Scientist BioSeparations
USA - New Jersey - Rahway

BioSeparations Filtration Systems Viral Clearance Downstream process development Digital twins Downstream processing Industry 4.0 JMP Facility fit +79

Senior Full Time

USD 111K+

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 Scientist, Biostatistics, Early Development Statistics
USA - New Jersey - Rahway

Experimental medicine Scientific Principles Research decision sciences Regulatory Approval Statistical Methodology Clinical Pharmacology Early clinical development Product Discovery Biomarkers +57

Senior Mid Full Time

USD 111K+

Cybersecurity Specialist
United States of America : Remote

Security governance Quality Management Systems Mitigation Industry Best Practices Quality Management System Regulatory Submissions FDA Diabetes Care Cross-functional Teams +24

USD 83K+

Senior Manager, Consumer Marketing, Ophthalmology (Rare Disease) Remote
US - Illinois - Chicago - Field/Remote

Paid search management CRM strategy KPI planning Organic search management Search engine optimization Website Development KPI Ophthalmology Insight +27

Senior Full Time

USD 152K+

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+

Medical Director
USA - Remote

Clinical/anatomic pathologist Clinical chemist Immunoassays Clinical pathologist In vitro diagnostics Clinical Laboratory Laboratory Diagnostics Adverse event reporting Flow cytometry +22

Exec Mid Full Time

USD 285K+

Senior Director Nonclinical Development
United States Remote Office

Preclinical protocols Nonclinical development SOP comprehension Written presentation Analytical sciences Oral Presentation Toxicology GLP Pharmacology +29

Senior Full Time

USD 151K+

Senior Statistician - NMPH - Rice Creek, MN or Remote Within US
USA-MN

Survival analysis Bayesian Methods Pelvic Health Statistical Methodology Research & Development Healthcare Access Healthcare Solutions Statistical Programming Neuromodulation +26

Senior Full Time

USD 174K+

Senior Director, Manufacturing, Science and Technology - Drug Product
Remote (United States)

PTC Therapeutics, Inc.

Manufacturing science Process Validation Process Control ICH Guidelines Contract negotiations GMP Regulatory Submissions Process Development Biotechnology +17

Senior Full Time

USD 198K+

Global Head of Quality Assurance, Medical Adhesive Technologies
USA-Virtual

Supplier Quality Management EU MDR Fault tree analysis FMEA CAPA ISO 13485 FDA regulations Quality Management System Regulatory Submissions +6

Exec Senior Full Time

USD 180K+

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+

Principal Medical Writer
Remote (US)

Regulatory Writing Clinical Study Protocols BLA Clinical Study Reports Regulatory Documents Medical Writing Life Science Protocols Adobe Acrobat +32

Senior Full Time

USD 116K+

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+

Clinical Research Medical Director, Endocrinology/Sleep Apnea, US - Remote
US - California - Thousand Oaks - Field/Remote

Sleep disorders Key Opinion Leader Engagement International regulatory requirements Pharmaceutical Product Development Basic Science Research Obesity Clinical trial data Regulatory Interactions Leadership Attributes +50

Exec Mid Full Time

USD 256K+

Associate Director, Biostatistics
Remote - United States

Bristol Myers Squibb

Programming collaboration Radiopharmaceuticals ICH Guidelines Cell Therapy Study Design Regulatory Submissions Biostatistics Advanced Analytics Biotechnology +9

Senior Mid Full Time

USD 167K+

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+

Associate Manager, Regulatory Operations
Remote (US)

Biopharmaceutical project management Regulatory project management ICH Requirements Regulatory operations Regulatory Documents Regulatory strategy Entrepreneurial Mindset MS Project Financial excellence +27

USD 95K+

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+

Clinical Research Medical Director - Obesity/MASH, US - Remote
US - California - Thousand Oaks - Field/Remote

Metabolic diseases Safety Assessments Basic Science Research Clinical trial data Obesity Regulatory Interactions Clinical Study Reports Metabolic QC +24

Exec Mid Full Time

USD 256K+

Senior Director, Biostatistics- Obesity/ Cardiometabolic
US - California - Thousand Oaks - Field/Remote

Health technology assessments Statistical leadership Obesity Metabolic Scientific research Payer Data Insights Strategic development Clinical Data +36

Senior Full Time

USD 220K+

Medical Sciences Director - Late Development, Thoracic Oncology
US - California - Thousand Oaks - Field/Remote

Data quality assessment Translational science Clinical trial data Regulatory Interactions Spotfire Insight Protocol Development Data Cleaning Clinical Data +36

Exec Senior Full Time

USD 220K+

Senior Manager, Statistical Programming
Remote - United States

Statistical Concepts Clinical Data Management Clinical Data Statistical Programming Regulatory Submissions Product Launch Clinical Development People Management SAS +17

Senior Full Time

USD 145K+

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+

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+

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+

Assoc Dir Health Economics & Outcomes Research
SLEEPY HOLLOW

Cost-Effectiveness Analysis Real World Data Analysis Meta-Analysis Evidence Synthesis Budget Impact Modeling Health technology assessment Observational Research Reimbursement strategies HEOR +13

Senior Full Time

USD 170K+

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+

Manager, Regulatory Affairs (Clinical Submissions)
US-Nationwide-FIELD

Cardinal Health

Clinical Submissions Clinical Document Preparation Electronic Submission Systems Regulatory Software Regulatory Documentation Regulatory strategy Clinical Trial Design Pay equity Regulatory Submissions +17

Senior Full Time

USD 121K+

Principal Scientist (ADC), Sterile Drug Product Commercialization
USA - Pennsylvania - West Point

Continuous process optimization Antibody-drug conjugate In-process controls Facility fit Manufacturing science Analytical Technologies Drug Product Commercialization Shelf-life strategies Scale-down +100

Senior Full Time

USD 164K+

Director, Pharmacometrics
USA - Pennsylvania - Plymouth Meeting

GastroPlus Simcyp GLP Modeling and Simulation Pharmacometrics Monolix Nonmem Clinical Pharmacology Phoenix +19

Exec Senior Full Time

USD 150K+

Associate Principal Scientist (ADC), Sterile Drug Product Commercialization
USA - Pennsylvania - West Point

Sterile Products Antibody-drug conjugate In-process controls Drug Product Commercialization Facility fit Analytical Technologies Manufacturing science Shelf-life strategies Multivariate analysis +101

Senior Mid Full Time

USD 135K+

Associate/Manager - Regulatory Project Management and Operations
US: USA Remote

Eli Lilly and Company

Regulatory management systems ECTD publishing systems Document management systems Volunteerism Philanthropy Microsoft Applications Regulatory Submissions Proofreading Regulatory Affairs +8

USD 61K+

Biostatistics Sr Manager
US - California - Thousand Oaks - Field/Remote

Statistical leadership Cross-cultural communication SAS programming EDC Statistical techniques Statistical Programming Regulatory Guidelines Publications Regulatory Submissions +31

Senior Mid Full Time

USD 157K+

Senior Director of Medical Safety and Compliance
USA - Remote

Clinical Innovation Medical Safety In vitro diagnostics Clinical Laboratory Adverse event reporting Clinical Consultation Regulatory Submissions Risk assessments Medical Affairs +19

Senior Full Time

USD 300K+

Senior Patient Safety Physician - Psychiatrist (Remote)
Ridgefield, CT, United States, Connecticut

Boehringer Ingelheim

Patient Safety Epidemiology Pharmacovigilance Regulatory Submissions Biostatistics Medical Affairs Clinical trials Strategic planning Risk Management +3

Senior Full Time

USD 183K+

Senior Scientist, Preclinical Development- Formulations
USA - New Jersey - Rahway

Rheology Patent applications Texture analysis Statistical experimental design Pharmaceutics Veterinary Formulation Development Material science Technical Report Writing +44

Senior Mid Full Time

USD 111K+

Senior Patient Safety Physician - Oncology (Remote)
Ridgefield, CT, United States, Connecticut

Boehringer Ingelheim

Safety analysis Patient Safety Epidemiology Pharmacovigilance Regulatory Submissions Biostatistics Medical Affairs Clinical trials Team Leadership +4

Senior Full Time

USD 250K+

Sr Clinical Trial Design & Development Manager
Remote

Personalized medicine Protocols Clinical Trial Design Cell-free DNA Orientation Collection Genetic Testing Regulatory Submissions Regulatory standards +30

Senior Full Time

USD 114K+

Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics
USA - Pennsylvania - North Wales (Upper Gwynedd)

CMC regulatory strategies Regulatory CMC Health authorities CMC regulatory strategy BLA IND Virology Technology development Scientific Excellence +50

Senior Full Time

USD 181K+

PET Advanced Application Specialist
Remote

Radiochemistry Site qualification Automated synthesizers Radiopharmaceuticals Pharmaceutical diagnostics Medical Imaging Pharmaceutical manufacturing PET Technology Transfer +28

Senior Mid Full Time

USD 93K+

Director, Inspection Readiness and Clinical Oversight
United States Remote Office

IWRS ECRFs Clinical Project Management ETMF CTMS Clinical Trial Management ICH Regulatory Submissions SOPS +28

Exec Senior Full Time

USD 112K+

Principal Scientist-Biologics Potency, Cell Based Sciences, AR&D
USA - New Jersey - Rahway

Reporter gene assays NK cell assays GxP potency assays Biologics potency assays Cell line engineering Large molecule portfolio Scientific mentoring Mechanism-of-action assays Binding assays +60

Senior Full Time

USD 149K+

Senior Manager, Regulatory Diagnostics
Remote (US)

ECTD CTD Regulatory Documentation Regulatory Guidance Protocols Regulatory strategy ICH Guidelines Regulatory knowledge Adobe Acrobat +31

Senior Full Time

USD 135K+

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