Regulatory affairs courses can help you learn how laws, guidelines, and review processes shape the development and approval of products in regulated industries. You can build skills in documentation practices, compliance evaluation, quality systems, and interpreting regulatory requirements. Many courses introduce frameworks, submission tools, and case examples that support understanding how regulatory decisions are assessed and managed.

University of Pennsylvania
Skills you'll gain: Compliance Training, Compliance Management, Health Insurance Portability And Accountability Act (HIPAA) Compliance, General Data Protection Regulation (GDPR), Medical Privacy, Regulation and Legal Compliance, Legal Risk, Information Privacy, Governance Risk Management and Compliance, Personally Identifiable Information, Compliance Reporting, Law, Regulation, and Compliance, Regulatory Compliance, Regulatory Requirements, Compliance Auditing, Internal Communications, Procedure Development, Business Ethics, Risk Management, Business Strategy
Intermediate · Specialization · 3 - 6 Months

University of California San Diego
Skills you'll gain: Drug Development, Clinical Trials, Pharmaceuticals, Clinical Research, Commercialization, Pre-Clinical Development, Good Clinical Practices (GCP), Pharmacotherapy, Pharmacology, Regulatory Affairs, Intellectual Property, Sales Strategy, Biotechnology, Portfolio Management, Bioinformatics, Precision Medicine, Strategic Partnership, Regulatory Compliance, Marketing, Marketing Strategies
Beginner · Specialization · 3 - 6 Months

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
Beginner · Course · 1 - 4 Weeks

University of California San Diego
Skills you'll gain: Drug Development, Clinical Trials, Clinical Research, Pre-Clinical Development, Good Clinical Practices (GCP), Regulatory Affairs, Pharmacology, Regulatory Compliance, Commercialization, Patient Safety
Beginner · Course · 1 - 3 Months

University of Glasgow
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
Beginner · Course · 1 - 4 Weeks

Johns Hopkins University
Skills you'll gain: Drug Development, Clinical Trials, Pharmaceuticals, Clinical Research, Pre-Clinical Development, Pharmacology, Medical Devices, Statistical Analysis, Epidemiology, Health Policy, Regulatory Compliance, Data Collection
Mixed · Course · 1 - 4 Weeks

Johns Hopkins University
Skills you'll gain: Pharmacology, Pharmaceuticals, Patient Safety, Clinical Research, Medical Prescription, Pharmacotherapy, Clinical Trials, Epidemiology, Regulatory Compliance, Health Policy, Continuous Monitoring, Public Health, Event Monitoring, Risk Analysis
Mixed · Course · 1 - 4 Weeks

Vanderbilt University
Skills you'll gain: Clinical Data Management, Electronic Data Capture (EDC), Data Management, Data Collection, Case Report Forms, Data Sharing, Health Informatics, Data Strategy, Data Quality, Good Clinical Practices (GCP), Sampling (Statistics), Data Integrity, Data Validation, Regulatory Compliance
Beginner · Course · 1 - 3 Months

University of Illinois Urbana-Champaign
Skills you'll gain: Good Manufacturing Practices, Nutrition and Diet, Regulatory Affairs, Safety Standards
Intermediate · Course · 1 - 4 Weeks

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
Beginner · Course · 1 - 3 Months

Coursera
Skills you'll gain: Governance, Stakeholder Engagement, Law, Regulation, and Compliance, Regulatory Compliance, Compliance Management, Risk Management, Business Ethics, Stakeholder Management, Corporate Strategy, Corporate Communications, Enterprise Risk Management (ERM), Business Management, Environmental Social And Corporate Governance (ESG), Ethical Standards And Conduct, Organizational Structure, Crisis Management, Accountability, Financial Reporting
Beginner · Course · 1 - 4 Weeks

Skills you'll gain: Occupational Safety and Health Administration (OSHA), Occupational Safety And Health, Safety Training, Health And Safety Standards, Safety Standards, Safety Culture, Environment Health And Safety, Regulatory Compliance, Labor Law, Workers Compensation
Intermediate · Course · 1 - 4 Weeks
Browse the regulatory affairs courses below—popular starting points on Coursera.
Yes. You can start learning regulatory affairs skills on Coursera for free in two ways:
If you want to keep learning, earn a certificate in regulatory affairs, or unlock full course access after the preview or trial, you can 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.‎