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Regulatory Submissions Remote Jobs

75 fresh jobs found

Senior Principal Device Technical Working Group Lead (Senior Director Equivalent)
USA - New Jersey - Rahway, United States

Human factors analysis Injection molding Automated assembly EN 62366 Device design Device technology Quality system regulation Medical device development Manufacturing process development +78

Senior Full Time

USD 169K+

Associate Director, Regulatory Affairs Advertising and Promotion
US - WA - offsite, Estados Unidos

Gilead Sciences

Promotional Review Labeling Therapies Commercial Strategy FDA regulations Regulatory Submissions Regulatory Affairs Vision Dental +19

USD 165K+

Senior Regulatory Affairs Scientist
USA - Remote, United States

Scientific Guidance IVDR Clinical Testing MDR Diagnostic Tools ISO 13485 FDA regulations Biochemistry Statistical methods +20

Senior Full Time

USD 120K+

Senior Biostatistician (FSP)
Durham, North Carolina, United States of America

Biomarker analyses Multivariate analyses Exploratory analyses CDASH Bayesian Methods Clinical trial protocols Statistical analysis plans Simulations ADaM +30

Senior Full Time

USD 122K+

Principal Scientist, Analytical R&D
USA - New Jersey - Rahway, United States

Biological characterization Scientific publishing Non-gmp characterization Structure function assessment CRISPR Analytical control strategy High-content imaging Translational science Cell line engineering +91

Senior Full Time

USD 153K+

Associate Principal Scientist, Analytical R&D
USA - New Jersey - Rahway, United States

Specification setting Novel technologies Analytical control strategy High-throughput experimentation Analytical methodologies Peer coaching Peptides Drug conjugates Drug delivery +84

Senior Mid Full Time

USD 139K+

Principal Scientist, Analytical Research & Development
USA - New Jersey - Rahway, United States

Specification setting Analytical control strategy Novel technologies High-throughput experimentation Analytical methodologies Peer coaching Peptides Drug conjugates Method development +84

Senior Full Time

USD 149K+

Sr. Scientist, Engineering
USA - Pennsylvania - West Point, United States

Manufacturing science Drug Product Manufacturing Spr Manufacturing investigations Biochemical engineering Life cycle management Regulatory Documentation Scale-down DOE +75

Senior Full Time

USD 114K+

Technical Compliance Coordinator
USA - Remote

Rush Street Interactive

Technical compliance Technical Product Knowledge Regulatory Submissions Detail oriented Jira Verbal communication Regulatory Compliance Written communication Cross-functional Collaboration +4

USD 50K+

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+

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+

Assoc Prin. Scientist, Biologics Potency, CBS, Analytical R&D
USA - New Jersey - Rahway, United States

Biologics Potency Assays Cytotoxicity Assays Binding assays GxP Potency Assays Reporter Gene Assays Biologics Potency Cell line engineering Monoclonal Antibodies Drug conjugates +65

USD 139K+

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+

Associate Director, Global Biomarker Lead – Oncology Clinical Biomarkers
US - California - Thousand Oaks - Field/Remote, United States

Biomarker research Mechanisms of resistance Biomarker innovation Disease biology Biomarker platforms Clinical trial samples Patient stratification Biomarker Analysis Biomarker Strategies +34

USD 178K+

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

Boehringer Ingelheim

Safety analysis Patient Safety Epidemiology Pharmacovigilance Biostatistics Regulatory Submissions Pharmaceutical Industry Medical Affairs Clinical trials +7

Senior Full Time

USD 250K+

Senior Manager, Analytical Development
New York, New York

Axsome Therapeutics Inc

Dissolution KF Stability Programs Particle Size Analytical Development Method validation Method development HPLC GC +19

Senior Full Time

USD 120K+

Associate Principal Scientist (Associate Director Equivalent), Device Risk Management
USA - New Jersey - Rahway, United States

Empirical evidence Risk control measures Post market surveillance Combination product development Hazard Analysis Device development Clinical evaluations Process Enhancement ISO 14971 +53

Senior Mid Full Time

USD 139K+

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+

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+

Principal Biostatistician FSP, RWE
Durham, North Carolina, United States of America

Clinical trial protocols Iqvia Statistical analysis plans Data Sources Observational Research Statistical models ICH GCP Real-World Evidence Study Design +28

Senior Full Time

USD 131K+

Associate Manager, Regulatory Project Management
Remote (US), United States

Regulatory Project Management ICH Requirements Employee stock purchase plan Regulatory Documents Regulatory strategy Financial excellence Document management ICH Microsoft Project +27

USD 94K+

Clinical Study Manager (Remote)
Michigan, Portage 3800 East Centre Ave, United States

Medical Device Experience Clinical Trial Management Systems (CTMS) Electronic Trial Master File (eTMF) Clinical Evidence Strategy Good Clinical Practice (GCP) Publication strategy EU MDR Clinical evaluations Clinical evaluation +39

Senior Mid Full Time

USD 87K+

Principal Statistician
Your Remote US Home Office

Hypothesis Development Compliance principles Research Design Statistical reporting Statistical Programming ICH Regulatory Submissions Quality Management System Spreadsheets +21

Senior Full Time

USD 169K+

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+

Associate Director, Medical Writing
US - MA - offsite, Estados Unidos

Gilead Sciences

Document Strategy Clinical Study Reports Therapies Medical Writing Regulatory Submissions Drug Development Vision Dental Clinical trials +19

Senior Mid Full Time

USD 165K+

Senior Clinical Evidence Specialist - Fridley, MN (onsite) or Remote within US
USA-MN, United States

Evidence Strategy Development Medical Evidence Analysis Publication planning Research & Development Clinical evaluation Literature review Clinical evidence Healthcare Access Study Design +25

Senior Full Time

USD 154K+

Associate Principal Scientist, Engineering
USA - New Jersey - Rahway, United States

Biological Engineering Design Expert JMP Drug substance commercialization Manufacturing investigations Downstream processing Multivariate analysis Performance qualification Experiment Design +80

Senior Mid Full Time

USD 139K+

Clinical Research Senior Medical Scientist, Endocrinology - US, Remote
US - California - Thousand Oaks - Field/Remote, United States

Key opinion leader development Safety assessments Metabolic Medical Monitoring Basic Science Research Scientific method Regulatory Interactions Obesity Clinical trial data +27

Senior Mid Full Time

USD 168K+

Principal Clinical Scientist
United States of America : Remote

Clinical Study Protocols Scientific publications Quality System Environment Clinical Study Reports Clinical Strategies Operating procedures Quality System Evidence Generation Publications +26

Senior Full Time

USD 97K+

Senior Scientist, Engineering
USA - New Jersey - Rahway, United States

Biological Engineering Design Expert Downstream purification JMP Multi-disciplinary teamwork Drug substance commercialization Downstream processing Performance qualification Process Performance +70

Senior Mid Full Time

USD 114K+

Regulatory Project Manager / Sr. Project Manager, Regulatory Affairs
Remote - United States

Global Submissions Report Management Dashboard Creation Regulatory Submissions Regulatory Affairs Risk Assessment Pharmaceutical Cross-functional Collaboration Project Management +4

Senior Mid Full Time

USD 125K+

Sr Specialist R&D
REMOTE- Illinois, United States

Medline Industries, LP

FDA requirements Stability testing Audit leadership Strategic initiative development ANDA 510k OOS investigations ASTM Chemical characterization +29

Senior Mid Full Time

USD 85K+

Quality Compliance Senior Manager
US - California - Thousand Oaks - Field/Remote, United States

GCP Audits Vendor Qualification Biosimilars Regulatory inspections Quality oversight Inspection Readiness Global regulations Health authorities Quality by design +50

Senior Full Time

USD 147K+

Senior Manager, Safety Scientist
Remote (US), United States

Judgment-based decision making Safety Data Evaluation Signal Assessment Global Regulatory Requirements CTA Product safety Signal detection Clinical trial support Safety Assessment +46

Senior Full Time

USD 142K+

Lead Bioinformatician
US Remote

Cnv analysis Variant calling Statistical Methodology Algorithm Design Bioinformatics Cell-free DNA Statistical methods Protocols Regulatory Submissions +25

Senior Full Time

USD 157K+

Nonclinical Regulatory Writing and Submission Support, Sr. Manager
USA - MA - Virtual, United States

Biologic license applications Marketing authorization applications Lean authoring New drug applications Clinical Trial Applications EMA Global Regulatory Affairs Regulatory Writing Investigational new drug applications +33

Senior Full Time

USD 133K+

Director, Nonclinical Regulatory Writing and Submission Support, Team Lead
USA - MA - Virtual, United States

New drug applications Biologic license applications Marketing authorization applications Clinical Trial Applications EMA Global Regulatory Affairs Regulatory Writing Toxicology Robotic Process Automation +45

Senior Full Time

USD 169K+

Associate/Director of Biostatistics, Rare Disease, FSP
Durham, North Carolina, United States of America

Sample size calculations Statistical analysis plans Statistical Methodology ADaM CDISC Good Clinical Practice Data Review Statistical methods Regulatory Submissions +29

Exec Senior Full Time

USD 161K+

Chief Medical Safety Officer; VP, Clinical Oversight & Innovation
Remote US

Clinical Innovation Medical oversight Cardiac monitoring Clinical Oversight Scientific Leadership Scientific research FDA regulations Workflow Regulatory Submissions +24

Exec Senior Full Time

USD 287K+

Sr Clinical Scientist
Remote

Molecular therapeutics Personalized medicine Clinical Trial Design Cell-free DNA Protocols Biostatistics Collection Regulatory Submissions Orientation +34

Senior Full Time

USD 114K+

Clinical Study Manager
Your Remote US Home Office

Clinical Study Management CFR Budget negotiation Compliance principles Vendor oversight Audit readiness Protocol Development Good Clinical Practice Regulatory Submissions +24

USD 123K+

Associate Director/Director of Statistical Programming
Remote Opportunity - Canada · Remote Opportunity - United Kingdom · Remote Opportunity - United States

R-Shiny ADaM SDTM Data Standards CDISC Statistical Programming Data Review Regulatory Guidelines Regulatory Submissions +12

Senior Mid Full Time

USD 162K+

Principal Scientist, Biologics Potency, Analytical R&D
USA - New Jersey - Rahway, United States

GxP Potency Assays Biologics Potency Natural Killer Cell Assays Reporter Gene Assays Cell line engineering Drug conjugates Monoclonal Antibodies Antibody-drug conjugates Method development +64

Senior Full Time

USD 153K+

Senior Manager, Regulatory Affairs
US Remote, United States

Class III Implants Connected Care Products Quality Systems Motivational Clinical Trial Design Medical Technology Regulatory Submissions Healthcare systems Regulatory Affairs +14

Senior Full Time

USD 140K+

Director, Biologics and Biopharmaceutics
USA - New Jersey - Rahway, United States

Formulation Design Monoclonal Antibodies Disease mechanisms Biopharmaceutics GMP Compliance MAbs Drug-Device Combinations Sterile Product Development Scientific Methodology +119

Exec Senior Full Time

USD 164K+

UNIV - Lead Regional Research Program Manager - Department of SCTR
Remote- South Carolina, United States

Medical University of South Carolina

Research Compliance Supporting Communication Planning Budget development Regulatory Submissions Clinical Research Auditing Monitoring Project Management +3

Senior Mid Full Time

USD 68K+

Associate Director, Regulatory Information Management
USA - MA - Virtual, United States

Procedure Development Health Authority Interaction Global Regulatory Affairs Regulatory information management Document management Regulatory Submissions Regulatory Affairs KPI development Drug Development +26

Senior Mid Full Time

USD 149K+

AVP, Global Clinical Supply
USA - Pennsylvania - West Point, United States

Program Leadership Clinical trial execution Drug product development Clinical supply chain Clinical Supply Clinical supplies CGMP Pharmaceutical Sciences Collaborative relationships +60

Exec Senior Full Time

USD 276K+

Sr. Scientist, Engineering
USA - Pennsylvania - West Point, United States

Manufacturing investigations Therapeutic proteins Regulatory Submission Tech Transfer GMP manufacturing Current good manufacturing practices Process Validation Large Molecule Process Characterization +37

Senior Mid Full Time

USD 114K+

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