Regulatory Science
The Regulatory Science program provides a thorough academic foundation for understanding how scientific innovation, product development, and regulatory frameworks intersect within healthcare, biotechnology, and pharmaceutical industries. Students explore the scientific, legal, and policy standards that govern the approval, monitoring, and evaluation of medical products, gaining strong competencies in regulatory strategy, compliance practices, and evidence assessment. With coursework that integrates chemistry, risk analysis, and regulatory policy, the program helps learners understand how scientific data supports regulatory decisions and protects public health. This structured yet flexible curriculum is designed for working professionals seeking to deepen their expertise in a highly specialized and rapidly evolving field.
In addition to theoretical instruction, the program emphasizes practical application through case analyses, simulated regulatory submissions, and exposure to real-world compliance challenges. Students interact with faculty who have extensive experience in regulatory agencies, industry leadership, and scientific research, allowing them to understand how regulations shape innovation and product safety. Engaging with topics such as clinical trial oversight, quality systems, and global regulatory pathways strengthens students’ abilities to evaluate scientific evidence and guide organizational strategy. With a strong emphasis on risk management, regulatory communication, and interdisciplinary problem-solving, the program equips graduates with the insight and technical skill needed to make informed contributions to scientific and regulatory environments.
Key information
Key Facts
- Program Title: Regulatory Science
- Degree Type: Master of Science
- Duration: 20 months
- Mode of Study: Part-time, Online
- Application Deadline: 20 February 2026
- Location: Johns Hopkins University, United States
- Field of Study: Chemistry
- Language of Instruction: English
Program Structure
Semester 1 – Foundations of Regulatory Science
• Principles of Regulatory Affairs
• Chemistry of Medical Products
• Introduction to Risk Assessment
• Regulatory Writing and Documentation
Semester 2 – Applied Regulatory Processes & Compliance
• Drug and Biologic Development Pathways
• Clinical Research Oversight
• Good Manufacturing and Laboratory Practices
• Data Integrity and Regulatory Ethics
Semester 3 – Advanced Regulatory Strategy & Evaluation
• Global Regulatory Frameworks
• Quality Systems and Compliance Management
• Benefit–Risk Assessment
• Elective in Pharmaceutical Policy or Toxicology
Semester 4 – Capstone & Professional Integration
• Regulatory Science Capstone Project
• Advanced Seminar in Regulatory Innovation
• Scientific Communication for Regulatory Professionals
• Elective Module in Medical Device Regulation or Public Health Policy
Career Opportunities
Graduates of this program pursue roles across pharmaceutical companies, biotechnology firms, medical device organizations, and regulatory agencies, where they support regulatory submissions, ensure compliance with quality standards, and evaluate scientific evidence for product approval. Many also work in consulting, clinical research organizations, academic centers, and global health institutions, contributing to regulatory strategy, safety assessment, and post-market surveillance. With strong capabilities in scientific review, data interpretation, and regulatory planning, graduates are well prepared to advance into roles such as regulatory affairs specialist, compliance manager, quality systems analyst, and scientific evaluator.
Why Choose This Program
This program is an excellent choice for professionals seeking to deepen their understanding of how scientific evidence informs regulatory decisions while developing the leadership and analytical skills needed to excel in highly regulated industries. The curriculum builds strength in scientific evaluation, regulatory communication, and strategic compliance, preparing students to manage complex approval processes and guide organizational decision-making. The part-time online format offers flexibility for working professionals, allowing learners to immediately apply new insights to their current roles while advancing academically. Access to faculty with real regulatory experience, exposure to current industry practices, and opportunities to complete applied projects provide a rich learning environment grounded in real-world challenges. Ultimately, this degree equips graduates with the expertise, confidence, and professional grounding necessary to contribute meaningfully to scientific advancement, regulatory policy, and product safety across global health and industry sectors.
Contact Information
For further information, please contact the admissions office at:
Phone: +1 410 516 8000
Email: admissions@jhu.edu
Address: Johns Hopkins University, 3400 N. Charles Street, Baltimore, MD 21218, USA
