• For Individuals
  • For Businesses
  • For Universities
  • For Governments
Coursera
  • Log In
  • Join for Free
    Coursera
    • Browse
    • Regulatory Affairs

    Regulatory Affairs Courses

    Regulatory affairs courses can help you learn how to navigate laws, guidelines, and approval processes that govern healthcare products, medical devices, and pharmaceuticals.

    Skip to search results

    Filter by

    Subject
    Required
     *

    Language
    Required
     *

    The language used throughout the course, in both instruction and assessments.

    Learning Product
    Required
     *

    Level
    Required
     *

    Duration
    Required
     *

    Skills
    Required
     *

    Subtitles
    Required
     *

    Educator
    Required
     *

    Find the Best Regulatory Affairs Course for Your Goals

    • Status: New
      New
      Status: Preview
      Preview
      T

      Technical University of Munich (TUM)

      Biotech — From Science to Business

      Skills you'll gain: Business Modeling, Commercialization, Business Planning, Feasibility Studies, Business Marketing, Entrepreneurship, New Product Development, Market Opportunities, Business Development, New Business Development, Innovation, Business Strategies, Product Development, Pharmaceuticals, Value Propositions, Intellectual Property, Healthcare Industry Knowledge, Regulatory Requirements

      Intermediate · Course · 1 - 3 Months

    • Status: New
      New
      Status: Preview
      Preview
      M

      Macquarie University

      AI Security: Risks, Defences and Safety

      Skills you'll gain: Security Testing, Governance, Cybersecurity, Cyber Attacks, DevSecOps, Cyber Threat Intelligence, Data Ethics, Regulation and Legal Compliance, Threat Modeling, Security Engineering, Infrastructure Security, Data Security, Cyber Governance, Artificial Intelligence, Artificial Intelligence and Machine Learning (AI/ML), Risk Management, Machine Learning, Encryption, Application Programming Interface (API), Applied Machine Learning

      Beginner · Course · 1 - 3 Months

    • Status: Free Trial
      Free Trial
      J

      Johns Hopkins University

      Clinical Trials Operations

      Skills you'll gain: Clinical Data Management, Clinical Trials, Sample Size Determination, Clinical Research, Data Quality, Healthcare Ethics, Statistical Reporting, Data Entry, Data Management, Regulatory Compliance, Quality Assurance, Data Sharing, Medical Privacy, Science and Research, Data Integrity, Data Cleansing, Medical Science and Research, Data Collection, Biostatistics, Personally Identifiable Information

      4.7
      Rating, 4.7 out of 5 stars
      ·
      522 reviews

      Beginner · Specialization · 3 - 6 Months

    • Status: Free Trial
      Free Trial
      N

      Novartis

      Clinical Trials: Good Clinical Practice

      Skills you'll gain: Clinical Trials, Clinical Research, Healthcare Ethics, Pharmaceuticals, Record Keeping, Medical Science and Research, Patient Registration, Document Management, Regulatory Compliance, Patient Education And Counseling, Medical Privacy, Patient Safety, Risk Management

      4.7
      Rating, 4.7 out of 5 stars
      ·
      566 reviews

      Beginner · Specialization · 1 - 3 Months

    • Status: New
      New
      Status: Free Trial
      Free Trial
      J

      Johns Hopkins University

      Drug Development and Pharmacoepidemiology

      Skills you'll gain: Clinical Trials, Clinical Research, Pharmaceuticals, Medication Therapy Management, Pharmacotherapy, Pharmacology, Health Policy, Research Design, Medical Prescription, Research Methodologies, Patient Safety, Science and Research, Statistical Analysis, Program Evaluation, Medical Science and Research, Epidemiology, Regulatory Compliance, Healthcare Industry Knowledge, Public Health, Data Analysis

      4.6
      Rating, 4.6 out of 5 stars
      ·
      29 reviews

      Intermediate · Specialization · 3 - 6 Months

    • Status: Preview
      Preview
      Y

      Yale University

      Financial Markets

      Skills you'll gain: Financial Market, Investment Banking, Portfolio Management, Finance, Capital Markets, Financial Services, Corporate Finance, Derivatives, Investments, Financial Regulation, Risk Management, Behavioral Economics, Equities, Underwriting, Securities (Finance), Lending and Underwriting, Market Dynamics, Governance, Insurance, Environmental Social And Corporate Governance (ESG)

      4.8
      Rating, 4.8 out of 5 stars
      ·
      31K reviews

      Beginner · Course · 1 - 3 Months

    • Status: Free Trial
      Free Trial
      U

      University of Pennsylvania

      Privacy Law and HIPAA

      Skills you'll gain: Medical Privacy, Personally Identifiable Information, Information Privacy, Law, Regulation, and Compliance, General Data Protection Regulation (GDPR), Data Security, Regulation and Legal Compliance, Security Awareness, Data Governance, Threat Management, Compliance Management, Incident Response, Health Care Procedure and Regulation, Computer Security Incident Management, Risk Analysis

      4.6
      Rating, 4.6 out of 5 stars
      ·
      166 reviews

      Mixed · Course · 1 - 4 Weeks

    • Status: Free Trial
      Free Trial
      I

      IBM

      Cybersecurity Compliance Framework, Standards & Regulations

      Skills you'll gain: IT Service Management, Governance Risk Management and Compliance, Information Technology Infrastructure Library, Regulatory Compliance, Data Ethics, Compliance Management, Cyber Risk, Cyber Security Policies, NIST 800-53, Cybersecurity, Regulatory Requirements, Cyber Security Strategy, IT Automation, ISO/IEC 27001, General Data Protection Regulation (GDPR), Compliance Auditing, Artificial Intelligence, Payment Card Industry (PCI) Data Security Standards, Risk Management, Open Web Application Security Project (OWASP)

      4.7
      Rating, 4.7 out of 5 stars
      ·
      3.4K reviews

      Intermediate · Course · 1 - 3 Months

    • Status: Free Trial
      Free Trial
      U

      University of Pennsylvania

      What is Compliance?

      Skills you'll gain: Compliance Management, Regulatory Compliance, Legal Risk, Governance Risk Management and Compliance, Law, Regulation, and Compliance, Regulatory Requirements, Operational Risk, Financial Regulation, Risk Management, Governance, Risk Analysis, Auditing, Brand Management, Strategic Planning

      4.8
      Rating, 4.8 out of 5 stars
      ·
      1.4K reviews

      Mixed · Course · 1 - 4 Weeks

    • Status: Free Trial
      Free Trial
      U

      University of Pennsylvania

      Healthcare Law

      Skills you'll gain: Intellectual Property, Medical Privacy, Personally Identifiable Information, Information Privacy, Law, Regulation, and Compliance, Primary Care, General Data Protection Regulation (GDPR), Health Care Procedure and Regulation, Health Policy, Data Security, Health Administration, Regulation and Legal Compliance, Medicare, Health Systems, Security Awareness, Pharmaceuticals, Data Governance, Healthcare Industry Knowledge, Health Equity, Health Care

      4.7
      Rating, 4.7 out of 5 stars
      ·
      567 reviews

      Intermediate · Specialization · 3 - 6 Months

    • Status: Free Trial
      Free Trial
      U

      University of California San Diego

      Drug Discovery

      Skills you'll gain: Pharmaceuticals, Pharmacology, Clinical Trials, Bioinformatics, Laboratory Research, Chemistry, Medical Science and Research, Healthcare Industry Knowledge, Regulatory Affairs

      4.6
      Rating, 4.6 out of 5 stars
      ·
      3.9K reviews

      Beginner · Course · 1 - 3 Months

    • Status: Preview
      Preview
      U

      University of Manchester

      Industrial Biotechnology

      Skills you'll gain: Process Engineering, Chemical and Biomedical Engineering, Chemical Engineering, Biochemistry, Pharmaceuticals, Molecular Biology, Bioinformatics, Manufacturing and Production, Energy and Utilities, Environmental Engineering, Life Sciences, Biology, Manufacturing Processes, Pharmacology, Process Development, Microbiology, Scalability

      4.7
      Rating, 4.7 out of 5 stars
      ·
      3.5K reviews

      Beginner · Course · 1 - 3 Months

    1234…54

    In summary, here are 10 of our most popular regulatory affairs courses

    • Biotech — From Science to Business: Technical University of Munich (TUM)
    • AI Security: Risks, Defences and Safety: Macquarie University
    • Clinical Trials Operations: Johns Hopkins University
    • Clinical Trials: Good Clinical Practice: Novartis
    • Drug Development and Pharmacoepidemiology: Johns Hopkins University
    • Financial Markets: Yale University
    • Privacy Law and HIPAA: University of Pennsylvania
    • Cybersecurity Compliance Framework, Standards & Regulations: IBM
    • What is Compliance?: University of Pennsylvania
    • Healthcare Law: University of Pennsylvania

    Why Learn Regulatory Affairs?

    Regulatory affairs ensures that products like medications, medical devices, and biologics meet safety, efficacy, and compliance standards before reaching the market. It plays a critical role in aligning innovation with public health regulations. Learning regulatory affairs can help you understand approval pathways, manage documentation, and support global compliance in health-related industries.

    Other topics to explore

    Arts and Humanities
    338 courses
    Business
    1095 courses
    Computer Science
    668 courses
    Data Science
    425 courses
    Information Technology
    145 courses
    Health
    471 courses
    Math and Logic
    70 courses
    Personal Development
    137 courses
    Physical Science and Engineering
    413 courses
    Social Sciences
    401 courses
    Language Learning
    150 courses

    Coursera Footer

    Technical Skills

    • ChatGPT
    • Coding
    • Computer Science
    • Cybersecurity
    • DevOps
    • Ethical Hacking
    • Generative AI
    • Java Programming
    • Python
    • Web Development

    Analytical Skills

    • Artificial Intelligence
    • Big Data
    • Business Analysis
    • Data Analytics
    • Data Science
    • Financial Modeling
    • Machine Learning
    • Microsoft Excel
    • Microsoft Power BI
    • SQL

    Business Skills

    • Accounting
    • Digital Marketing
    • E-commerce
    • Finance
    • Google
    • Graphic Design
    • IBM
    • Marketing
    • Project Management
    • Social Media Marketing

    Career Resources

    • Essential IT Certifications
    • High-Income Skills to Learn
    • How to Get a PMP Certification
    • How to Learn Artificial Intelligence
    • Popular Cybersecurity Certifications
    • Popular Data Analytics Certifications
    • What Does a Data Analyst Do?
    • Career Development Resources
    • Career Aptitude Test
    • Share your Coursera Learning Story

    Coursera

    • About
    • What We Offer
    • Leadership
    • Careers
    • Catalog
    • Coursera Plus
    • Professional Certificates
    • MasterTrack® Certificates
    • Degrees
    • For Enterprise
    • For Government
    • For Campus
    • Become a Partner
    • Social Impact
    • Free Courses
    • ECTS Credit Recommendations

    Community

    • Learners
    • Partners
    • Beta Testers
    • Blog
    • The Coursera Podcast
    • Tech Blog

    More

    • Press
    • Investors
    • Terms
    • Privacy
    • Help
    • Accessibility
    • Contact
    • Articles
    • Directory
    • Affiliates
    • Modern Slavery Statement
    • Do Not Sell/Share
    Learn Anywhere
    Download on the App Store
    Get it on Google Play
    Logo of Certified B Corporation
    © 2025 Coursera Inc. All rights reserved.
    • Coursera Facebook
    • Coursera Linkedin
    • Coursera Twitter
    • Coursera YouTube
    • Coursera Instagram
    • Coursera TikTok