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    • 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.

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    Find the Best Regulatory Affairs Course for Your Goals

    • Status: Free Trial
      Free Trial
      U

      University of Pennsylvania

      What is Compliance?

      Skills you'll gain: Compliance Management, Compliance Training, Regulation and Legal Compliance, Legal Risk, Law, Regulation, and Compliance, Governance Risk Management and Compliance, Compliance Reporting, Regulatory Requirements, Compliance Auditing, Risk Management, Operational Risk, Risk Analysis

      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 Minnesota

      Healthcare Marketplace

      Skills you'll gain: Competitive Analysis, Payment Systems, Intellectual Property, Health Systems, Healthcare Industry Knowledge, Commercialization, Pharmaceuticals, Leadership Development, Health Care Administration, Product Management, Medical Management, Go To Market Strategy, Regulatory Affairs, Medical Equipment and Technology, Organizational Structure, Market Opportunities, Health Care, Market Analysis, Cost Benefit Analysis, Health Care Procedure and Regulation

      4.5
      Rating, 4.5 out of 5 stars
      ·
      1.5K reviews

      Beginner · Specialization · 3 - 6 Months

    • Status: Free Trial
      Free Trial
      U

      University of Pennsylvania

      Intellectual Property in the Healthcare Industry

      Skills you'll gain: Intellectual Property, Healthcare Industry Knowledge, Pharmaceuticals, Health Care Procedure and Regulation, Regulation and Legal Compliance, Legal Strategy, Medical Privacy, Health Policy, Medical Science and Research, Branding, Economics, Policy Analysis

      4.8
      Rating, 4.8 out of 5 stars
      ·
      139 reviews

      Beginner · Course · 1 - 4 Weeks

    • Status: Free Trial
      Free Trial
      U

      University of Pennsylvania

      Privacy Law and HIPAA

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

      4.6
      Rating, 4.6 out of 5 stars
      ·
      158 reviews

      Mixed · Course · 1 - 4 Weeks

    • U

      University of Manchester

      Industrial Biotechnology

      Skills you'll gain: Process Engineering, Molecular Biology, Chemical Engineering, Life Sciences, Biochemistry, Bioinformatics, Biology, Pharmaceuticals, Environmental Engineering, Manufacturing Processes, Process Development, Microbiology

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

      Beginner · Course · 1 - 3 Months

    • Status: Free Trial
      Free Trial
      U

      University of California San Diego

      Drug Commercialization

      Skills you'll gain: Commercialization, Pharmacotherapy, Pharmacology, Intellectual Property, Clinical Trials, Portfolio Management, Strategic Partnership, Regulatory Affairs, Product Marketing, Go To Market Strategy, Business Strategy, Marketing Strategies, Market Dynamics, Business Development

      4.7
      Rating, 4.7 out of 5 stars
      ·
      1.3K reviews

      Beginner · Course · 1 - 3 Months

    • Status: Free Trial
      Free Trial
      U

      University of California San Diego

      Drug Discovery

      Skills you'll gain: Pharmaceuticals, Pharmacology, Clinical Research, Bioinformatics, New Product Development, Medical Science and Research, Regulatory Affairs, Molecular Biology, Market Opportunities, Innovation, Chemistry

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

      Beginner · Course · 1 - 3 Months

    • K

      Knowledge Accelerators

      The ABC's of GDPR: Protecting Privacy in an Online World

      Skills you'll gain: General Data Protection Regulation (GDPR), Information Privacy, Personally Identifiable Information, Regulatory Compliance, Compliance Management, Data Security, Governance, Data Governance, Regulatory Requirements, Legal Risk, Data Collection

      4.9
      Rating, 4.9 out of 5 stars
      ·
      53 reviews

      Beginner · Course · 1 - 4 Weeks

    • Y

      Yale University

      Introduction to Medical Software

      Skills you'll gain: Clinical Trials, Software Development Life Cycle, Software Quality Assurance, Systems Development, Usability, Software Development, Medical Privacy, Human Computer Interaction, Verification And Validation, Risk Management, Medical Management, User Interface (UI), Health Care Procedure and Regulation, Software Design, Healthcare Industry Knowledge, Regulatory Compliance, Health Technology, Entrepreneurship, Artificial Intelligence and Machine Learning (AI/ML), Cybersecurity

      4.8
      Rating, 4.8 out of 5 stars
      ·
      262 reviews

      Intermediate · Course · 3 - 6 Months

    • K

      Korea Advanced Institute of Science and Technology(KAIST)

      Biochemical Principles of Energy Metabolism

      Skills you'll gain: Biochemistry, Respiration, Pathology, Biology, Life Sciences, Nutrition and Diet, Chronic Diseases, Molecular Biology, Clinical Nutrition, Internal Medicine, Oncology

      4.8
      Rating, 4.8 out of 5 stars
      ·
      814 reviews

      Beginner · Course · 1 - 3 Months

    • Status: Free Trial
      Free Trial
      S

      Stanford University

      AI in Healthcare Capstone

      Skills you'll gain: Patient Evaluation, Health Informatics, Clinical Data Management, Artificial Intelligence and Machine Learning (AI/ML), Data Collection, Applied Machine Learning, Application Deployment, Health Care Procedure and Regulation, Data Ethics, Machine Learning Software, Machine Learning, Healthcare Industry Knowledge, Predictive Modeling, Performance Tuning, Regulatory Compliance, Feature Engineering

      4.7
      Rating, 4.7 out of 5 stars
      ·
      257 reviews

      Mixed · Course · 1 - 3 Months

    • Status: Free Trial
      Free Trial
      T

      The Hong Kong University of Science and Technology

      FinTech Security and Regulation (RegTech)

      Skills you'll gain: Financial Regulation, Financial Regulations, Bank Regulations, FinTech, Financial Services, Financial Industry Regulatory Authorities, Law, Regulation, and Compliance, Regulatory Compliance, Mobile Banking, Regulatory Requirements, Regulatory Affairs, Risk Management, Data Security, Cybersecurity, Insurance, Blockchain, Threat Detection, Emerging Technologies

      4.7
      Rating, 4.7 out of 5 stars
      ·
      299 reviews

      Beginner · Course · 1 - 3 Months

    1234…53

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

    • What is Compliance?: University of Pennsylvania
    • Healthcare Marketplace: University of Minnesota
    • Intellectual Property in the Healthcare Industry: University of Pennsylvania
    • Privacy Law and HIPAA: University of Pennsylvania
    • Industrial Biotechnology: University of Manchester
    • Drug Commercialization : University of California San Diego
    • Drug Discovery : University of California San Diego
    • The ABC's of GDPR: Protecting Privacy in an Online World : Knowledge Accelerators
    • Introduction to Medical Software: Yale University
    • Biochemical Principles of Energy Metabolism: Korea Advanced Institute of Science and Technology(KAIST)

    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.

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