• For Individuals
  • For Businesses
  • For Universities
  • For Governments
Coursera
  • Online Degrees
  • Careers
  • 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
     *

    Build job-relevant skills in under 2 hours with hands-on tutorials.
    Learn from top instructors with graded assignments, videos, and discussion forums.
    Get in-depth knowledge of a subject by completing a series of courses and projects.
    Earn career credentials from industry leaders that demonstrate your expertise.
    Earn your Bachelor’s or Master’s degree online for a fraction of the cost of in-person learning.

    Level
    Required
     *

    Duration
    Required
     *

    Skills
    Required
     *

    Subtitles
    Required
     *

    Educator
    Required
     *

    Find the Best Regulatory Affairs Course for Your Goals

    • Status: New
      New
      A

      Alberta Machine Intelligence Institute

      Ethics and Responsible Practices in GenAI

      Skills you'll gain: Data Ethics, Business Ethics, Generative AI, Ethical Standards And Conduct, Artificial Intelligence, Law, Regulation, and Compliance, Regulatory Compliance, Regulatory Requirements, Governance, Information Privacy, Accountability, Social Studies, Data Security

      Beginner · Course · 1 - 4 Weeks

    • Status: New
      New
      A

      Arm

      Teaching AI on the Edge

      Skills you'll gain: Open Source Technology, Data Ethics, Artificial Intelligence, Education Software and Technology, Large Language Modeling, Generative AI, Artificial Intelligence and Machine Learning (AI/ML), Program Development, MLOps (Machine Learning Operations), Ethical Standards And Conduct, Application Deployment, Law, Regulation, and Compliance, Information Privacy, Performance Tuning, Data Security

      Beginner · Course · 1 - 3 Months

    • Status: New
      New
      Status: Free Trial
      Free Trial
      D

      Duke University

      Healthcare Leadership for Climate Change

      Skills you'll gain: Health Disparities, Health Equity, Design Thinking, Environmental Issue, Ethical Standards And Conduct, Initiative and Leadership, Advocacy, Community Organizing, Leadership, Personal Development, Environmental Science, Environment and Resource Management, Community Health, Visionary, Health Care, Innovation, Environment, Physical Science, Energy and Utilities, International Relations

      Beginner · Specialization · 1 - 3 Months

    • Status: New
      New
      C

      Coursera Instructor Network

      Operations Management in Healthcare- Streamlining Systems

      Skills you'll gain: Resource Utilization, Lean Methodologies, Operational Efficiency, Health Care Administration, Operations Management, Health Care Procedure and Regulation, Process Improvement, Systems Thinking, Health Technology, Workflow Management, Resource Allocation, Regulatory Requirements, Health Systems, Continuous Improvement Process, Cross-Functional Collaboration, Communication Strategies, Data-Driven Decision-Making

      Intermediate · Course · 1 - 4 Weeks

    • Status: New
      New
      C

      Coursera Instructor Network

      Responsible AI: Transparency & Ethics

      Skills you'll gain: Data Ethics, Artificial Intelligence, Compliance Management, Risk Mitigation, Regulatory Compliance, OpenAI, Ethical Standards And Conduct, Predictive Modeling, Business Ethics, Feature Engineering, Machine Learning, Diversity and Inclusion, Prompt Engineering, Exploratory Data Analysis, Auditing, Governance

      Intermediate · Course · 1 - 4 Weeks

    • Status: New
      New
      S

      Simplilearn

      Ethics of Generative AI

      Skills you'll gain: Data Ethics, General Data Protection Regulation (GDPR), Ethical Standards And Conduct, Generative AI, Business Ethics, Information Privacy, Personally Identifiable Information, Regulatory Compliance, Healthcare Ethics, Compliance Management, Artificial Intelligence, Data Security, Regulatory Requirements, Regulatory Affairs, Data-Driven Decision-Making, Accountability, Social Sciences

      Beginner · Course · 1 - 4 Weeks

    • Status: New
      New
      U

      University of Pennsylvania

      Refugee & Asylum Advocacy: Legal Frameworks for Protection

      Skills you'll gain: Advocacy, Immigration Law, Community and Social Work, Social Justice, Appeals, World History, Legal Research, Legal Proceedings, International Relations, Mental Health Diseases and Disorders

      Mixed · Course · 1 - 4 Weeks

    • Status: New
      New
      Status: Free Trial
      Free Trial
      D

      Duke University

      Art of the MOOC: Art, Culture, and Society

      Skills you'll gain: Color Theory, World Music, Disabilities, Art History, Diversity Awareness, Culture, Music History, Social Justice, Performing Arts, Music, Community Organizing, Liberal Arts, Peer Review, Musical Composition, Cultural Diversity, Music Theory, Pedagogy, International Relations, Social Sciences, Advocacy

      4.7
      Rating, 4.7 out of 5 stars
      ·
      323 reviews

      Beginner · Specialization · 3 - 6 Months

    • Status: New
      New
      C

      Coursera Instructor Network

      GenAI for Loan Officers: Revolutionizing Credit Scoring

      Skills you'll gain: Loan Origination, Lending and Underwriting, Consumer Lending, Commercial Lending, Workflow Management, Generative AI, Regulatory Compliance, Customer Communications Management, Compliance Management, Loans, Customer experience improvement, Credit Risk, Document Management, Financial Services, Business Process Automation, Artificial Intelligence, Ethical Standards And Conduct, Automation, Risk Management

      Intermediate · Course · 1 - 4 Weeks

    • Status: New
      New
      C

      Coursera Instructor Network

      WCAG Compliance: Web Accessibility Best Practices

      Skills you'll gain: Web Content Accessibility Guidelines, Compliance Auditing, Compliance Management, Regulatory Compliance, Usability, Web Design, User Interface (UI), Digital Content, Automation, Test Tools, Stakeholder Communications, Prioritization

      Intermediate · Course · 1 - 4 Weeks

    • Status: New
      New
      C

      Coursera Instructor Network

      Cybersecurity Strategies for AI-Driven Organizations

      Skills you'll gain: Threat Modeling, MITRE ATT&CK Framework, Cyber Security Strategy, Data Ethics, Cybersecurity, Penetration Testing, Threat Detection, Vulnerability Assessments, Artificial Intelligence, Data Security, Incident Response, Tensorflow, Risk Management Framework, Data Integrity

      Intermediate · Course · 1 - 4 Weeks

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

      Johns Hopkins University

      Drug Utilization: Trends, Determinants and Consequences

      Skills you'll gain: Pharmaceuticals, Medication Therapy Management, Pharmacotherapy, Medical Prescription, Pharmacology, Health Policy, Clinical Research, Patient Education And Counseling, Research Design, Epidemiology, Trend Analysis

      Mixed · Course · 1 - 4 Weeks

    1…456…53

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

    • Ethics and Responsible Practices in GenAI: Alberta Machine Intelligence Institute
    • Teaching AI on the Edge: Arm
    • Healthcare Leadership for Climate Change: Duke University
    • Operations Management in Healthcare- Streamlining Systems : Coursera Instructor Network
    • Responsible AI: Transparency & Ethics: Coursera Instructor Network
    • Ethics of Generative AI: Simplilearn
    • Refugee & Asylum Advocacy: Legal Frameworks for Protection: University of Pennsylvania
    • Art of the MOOC: Art, Culture, and Society: Duke University
    • GenAI for Loan Officers: Revolutionizing Credit Scoring: Coursera Instructor Network
    • WCAG Compliance: Web Accessibility Best Practices: Coursera Instructor Network

    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.

    Frequently Asked Questions about Regulatory Affairs

    Popular options include Regulatory Compliance from the University of Pennsylvania, and Quality Control and Regulatory in Cosmetic Science from Olay, which touch on regulatory pathways. While Coursera doesn’t offer a dedicated “regulatory affairs” specialization, many courses integrate essential compliance and policy concepts.‎

    Yes. Many courses relevant to regulatory affairs offer a free audit option, allowing learners to access video lectures and reading materials at no cost. To complete assignments or earn a certificate, you’ll need to upgrade or apply for financial aid.‎

    You’ll learn about the approval process for pharmaceuticals, medical devices, or food products; how to navigate regional and global regulations; and how to ensure product safety and efficacy. Courses may also introduce clinical trials, labeling, and post-market surveillance.‎

    Not necessarily. Many courses are designed for general learners and those exploring career options in regulatory affairs. For more technical courses—especially those that touch on drug development or clinical trials—some prior knowledge of biology or health sciences can be helpful.‎

    Yes. Regulatory affairs professionals are essential in ensuring that products meet compliance standards and reach the market safely. Coursera courses can help you build foundational knowledge, prepare for certification, and understand the global regulatory landscape.‎

    This FAQ content has been made available for informational purposes only. Learners are advised to conduct additional research to ensure that courses and other credentials pursued meet their personal, professional, and financial goals.

    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
    • Teaching Center

    More

    • Press
    • Investors
    • Terms
    • Privacy
    • Help
    • Accessibility
    • Contact
    • Articles
    • Directory
    • Affiliates
    • Modern Slavery Statement
    • Manage Cookie Preferences
    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