Regulatory Affairs

Regulatory Affairs is a critical discipline in the highly regulated industries like pharmaceuticals, medical devices, energy, and banking that ensures compliance with laws and regulations relevant to these fields. Coursera's Regulatory Affairs catalogue offers you comprehensive knowledge about regulatory strategy, submission, and compliance in various domains. You'll learn about the complex regulatory environment, how to prepare regulatory submission documentation and strategies, and the importance of post-market surveillance and regulatory enforcement. You'll also understand the role of a Regulatory Affairs professional in liaising with global regulatory agencies while ensuring the highest level of public safety.
4credentials
17courses

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Find the best Regulatory Affairs course for your goals

  • Status: Free Trial

    University of California San Diego

    Skills you'll gain: Drug Development, Clinical Trials, Pharmaceuticals, Clinical Research, Commercialization, Pre-Clinical Development, Pharmacotherapy, Pharmacology, Regulatory Affairs, Intellectual Property, Sales Strategy, Biotechnology, Portfolio Management, Bioinformatics, Precision Medicine, Strategic Partnership, Regulatory Compliance, Marketing, Marketing Strategies, Business Strategies

  • Status: Free Trial

    Skills you'll gain: Quality Control, Quality Assurance, Product Quality (QA/QC), Statistical Process Controls, Good Manufacturing Practices, Quality Management, Regulatory Affairs, Safety Standards, Chemistry, Regulatory Compliance, Product Testing, Standard Operating Procedure, Packaging and Labeling

  • Status: New
    Status: Free Trial

    University of Illinois Urbana-Champaign

    Skills you'll gain: Health Equity, Health Disparities, Social Determinants Of Health, Nutrition and Diet, Good Manufacturing Practices, Food Quality Assurance And Control, Nutrition Education, AI Personalization, Food Safety and Sanitation, Policy Development, Clinical Nutrition, Regulatory Affairs, Public Health, Regulatory Compliance, Health Policy, Health Informatics, Advocacy, Health Assessment, Health Technology, Microbiology

  • Status: Free Trial

    University of California San Diego

    Skills you'll gain: Drug Development, Clinical Trials, Clinical Research, Pre-Clinical Development, Regulatory Affairs, Pharmacology, Regulatory Compliance, Commercialization, Patient Safety

  • Status: Preview

    Skills you'll gain: Pharmaceuticals, Clinical Trials, Drug Development, Clinical Research Ethics, Healthcare Ethics, Good Clinical Practices (GCP), Pharmacology, Regulatory Affairs, Healthcare Industry Knowledge, Emerging Technologies, Regulatory Compliance, Precision Medicine, Biotechnology

  • Status: Free Trial

    University of California San Diego

    Skills you'll gain: Drug Development, Commercialization, Pharmaceuticals, Pharmacotherapy, Pharmacology, Intellectual Property, Sales Strategy, Clinical Trials, Portfolio Management, Strategic Partnership, Regulatory Affairs, Marketing Strategies, Business Strategies, Market Opportunities

What brings you to Coursera today?

  • Status: New
    Status: Free Trial

    University of Illinois Urbana-Champaign

    Skills you'll gain: Good Manufacturing Practices, Nutrition and Diet, Regulatory Affairs, Safety Standards

  • Status: Free Trial

    University of Minnesota

    Skills you'll gain: Competitive Analysis, Medical Devices, Payment Systems, Intellectual Property, Health Systems, Healthcare Industry Knowledge, Commercialization, Leadership Development, Health Care Administration, Managed Care, Product Management, Go To Market Strategy, Regulatory Affairs, New Product Development, Hospital Experience, Pharmaceuticals, Organizational Structure, Market Opportunities, Medical Equipment, Health Care

  • Status: Free Trial

    Skills you'll gain: Process Improvement, Continuous Improvement Process, Risk Management, Health Care Procedure and Regulation, Project Management Software, Workflow Management, Project Management, Collaborative Software, Collaboration, Team Oriented, Regulatory Affairs, Health Technology, Healthcare Industry Knowledge, Compliance Management, Key Performance Indicators (KPIs)

  • Status: Free Trial

    University of Minnesota

    Skills you'll gain: Healthcare Industry Knowledge, Pharmaceuticals, Medical Devices, Health Care, Health Technology, Market Dynamics, Medicare, Health Administration, Medicaid, Health Policy, Innovation, Cultural Diversity, Regulatory Affairs, Insurance, Market Trend, Stakeholder Analysis

  • Status: Preview

    Skills you'll gain: Clinical Trials, Software Development Life Cycle, Medical Devices, Usability, Software Development, Medical Privacy, Human Computer Interaction, Regulatory Affairs, Verification And Validation, Regulatory Requirements, Quality Management Systems, Biomedical Engineering, Risk Management, Software Design, Health Technology, Software Testing, Entrepreneurship, Artificial Intelligence and Machine Learning (AI/ML), User Research, Probability & Statistics

  • Status: New
    Status: Preview

    Skills you'll gain: Responsible AI, Data Ethics, General Data Protection Regulation (GDPR), Ethical Standards And Conduct, Business Ethics, Information Privacy, Case Studies, Regulatory Compliance, Artificial Intelligence, Regulatory Affairs, Social Studies

What brings you to Coursera today?

Leading partners

  • University of Minnesota
  • University of California San Diego
  • The State University of New York
  • University of Illinois Urbana-Champaign
  • Olay
  • Simplilearn
  • University of Colorado System
  • University of Pittsburgh