Master of Science in Health Sciences in Regulatory Affairs
Offered through the George Washington University School of Medicine and Health Sciences, the online Master of Science in Health Sciences (MSHS) in Regulatory Affairs program was developed in collaboration with regulatory affairs professionals working in industry and governmental agencies, including the Food and Drug Administration (FDA) and the National Institutes for Health (NIH).
The Masters in Regulatory Affairs program incorporates global regulatory strategy across the curriculum to develop strategic business leaders and equip you with the critical thinking skills needed in today's domestic and international job markets. Through the 36 credit-hour program curriculum, you'll complete the degree in two-years and gain an understanding of regulatory strategy that can be immediately applied to your career in the field.
Upon completion of the online MSHS in Regulatory Affairs program, you'll have learned the skills to advance to leadership positions in clinical research, FDA-regulated product development, patient advocacy, quality assurance, quality control, global regulatory strategy, and public health policy.
As a graduate of this program, you will be fully prepared to:
- Provide strategic direction and integrate business needs in matters of regulatory science and affairs in the health care industry.
- Lead and collaborate with the private sector and governmental stakeholders for effective development of medical products.
- Understand the philosophies and roles of the domestic and international regulatory agencies that oversee drugs, biologics, medical devices, and diagnostics.
- Evaluate the scientific and economic value of bringing new health care products into the global market.
- Analyze clinical trial and public health data to develop successful regulatory strategies.
- Navigate the submission and review process domestically and internationally.
- Manage regulatory aspects throughout the product lifecycle.
- Understand the factors that influence health care policy on a national and local level and how policies influence regulatory practice.
Who Is the Ideal Student for This Program?
The online MSHS in Regulatory Affairs program is ideal for health care professionals looking to lead regulatory strategy and product development in the evolving field of health care.
Regulatory affairs professionals play a pivotal role in the development, approval, and delivery of key medical advancements in today's dynamic global health care industry.
Designed to meet the growing demand for qualified professionals who can transform regulatory oversight, GWs MSHS in Regulatory Affairs program prepares graduates to fill a variety of roles including:
- Regulatory Affairs Specialist
- Regulatory Affairs Manager
- Chemistry, Manufacturing, and Controls (CMC) Manager
- Consumer Officer
- Technical Engineer
- Medical Affairs Associate
- Quality Assurance Engineer
Take Your Next Step
To learn more about the online Masters in Regulatory Affairs, contact an Admissions Advisor today at (844) 386-7323.
To be accepted to this program, you must have:
A bachelor's degree
Bachelors Degree from a Regionally Accredited Institution
3.0 GPA or above on a 4.0 scale
Previous work experience
Healthcare experience preferred.
A written personal statement
Statement of Purpose (Applicants must include a 250-500 word essay describing your reasons for undertaking study at GW, your academic objectives, career goals and related qualifications, including collegiate, professional, and community activities, relevant to your program of interest. Include any substantial accomplishments not already mentioned on the application form.)
Application Fee: A non-refundable application fee of $80 is required. The application fee is waived for active-duty U.S. military, current GW students, degree-holding GW alumni, current McNair Program Scholars.
2 Letters of Recommendation
Official transcripts from every college and university attended
International Students: Applicants who are not U.S. citizens are also required to submit official test scores for Test of English as a Foreign Language (TOEFL) or Pearson’s Test of English (PTE) Academics or the academic International English Language Test System (IELTS). The following are the minimum scores for admission consideration: TOEFL: 250 computer-based or 100 Internet-based GW's school code for the TOEFL is 5246. PTE: overall score of 86 IELTS: overall band score of 7.0, with no individual band score below 6.0 International applicants may be considered for admission without submitting the above scores if: You are a citizen of a country where English is the official language, You hold a bachelor’s degree from a country where English is the official language and language of instruction, You hold a bachelor’s degree from an institution accredited by a U.S. regional accrediting agency.
- Application Deadline
- Start Date
- December 10
- January 7
Allows students to think critically about leadership concepts by analyzing and evaluating academic articles associated with leadership, change management and systems development. Course is designed to use course content as a mechanism for developing critical thinking skills. This is a course that requires academic writing, contrasting and comparing and ideas and extrapolating current literature into practical application. The focus is on thinking.
You will examine clinical research and health care environments at the macro-level, which translates to identifying and examining the larger contemporary issues, trends, policies and pressures that influence and shape current clinical research and health care practices.
Develop a clinical research enterprise strategic plan, while analyzing business considerations, such as marketing, economic sustainability, fiscal management, quality improvement and integrating technology. Through the development of a strategic plan, you will build an understanding of the intricacies of leading and managing a business unit and management principles in assignments throughout the semester.
Provides an introduction to the foundation of biostatistics, which is comprised of the design and analysis of clinical research. Topics include distributions, populations and sample selection, variables, interaction and confounding, hypothesis formulation, correlation, t-tests, ANOVA, regression and chi-square analysis. In addition, the course will examine the interpretation of output from statistical software (SPSS and SAS). Practice problems and review of scientific literature are also included to provide a comprehensive context in public health.
Provides an introduction to the way epidemiologists explore individual characteristics and their influences on public health, identify risk factors and health disparities of disease and provide information for preventive medicine through the use of descriptive studies, surveillance and analytical studies. The basic concepts and methods of epidemiology and their application in measuring, studying and improving the health of populations are discussed.
Serves as a foundation for the entire program and is designed to provide students with a framework necessary to develop an integrated understanding of regulatory affairs. It looks at the big picture, covering U.S. and international legislation and regulatory processes guidelines, as well as the pivotal role that regulatory affairs leaders play in developing products, navigating the regulatory review and approval process and contributing to keeping products on the market.
Covers the development and evaluation of global regulatory strategies that support drug and biologic product development. In this course students analyze the critical elements of the product life cycle in the determination of a regulatory strategy, assess the roles of non-clinical and clinical data in determining regulatory strategy, appraise approaches for integrating strategic business needs into regulatory planning and evaluate the role of post-marketing efforts in shaping regulatory strategy.
Provides a framework for the development and evaluation of the regulatory affairs strategies that support device and diagnostics development. Objectives for this course are to analyze and evaluate the principle components of global regulatory strategy for devices and diagnostics, examine the regulation of medical devices through an epidemiological lens and analyze essential considerations associated with specific classifications or specialty areas of medical devices.
This course sources in the evaluation and assessment of regulatory strategies. Topics include protocol development, study design, post-marketing surveillance, evaluation and assessment of regulatory submissions. Through the framework of clinical trial design, we evaluate and assess strategies for achieving regulatory strategy in clinical development goals. The course introduces students to the planning and conduct of clinical trials. It provides an overview of clinical trials terminology and discusses issues related to clinical trial design. It discusses the components of a clinical trial including considerations regarding planning and carrying out a study. In the course we evaluate alternative clinical trial design options as conduits for achieving regulatory approval.
This course focuses on the analysis and evaluation of regulatory affairs compliance strategies and guidelines. Topics include pre- and post-marketing compliance, labeling, advertising and required reporting. In this course we identify and assess regulatory requirements, policies and guidelines associated with good practice (GXP) regulatory compliance issues. Students are required to critically analyze regulatory compliance issues and to integrate and develop implementation strategies for ensuring regulatory affairs compliance in medical product manufacturing, development, labeling and marketing. Students will need to demonstrate their ability to craft written regulatory communications including root cause analysis and corrective and preventive actions (CAPAs).
Theories of leadership and change are integrated in the development of change proposals for the regulatory affairs field. This is a capstone course focusing on the concept of leading change within the contexts of health professionals, health systems and health policy. Organizational, management and change theories, as well as characteristics of personal and professional change leadership, are explored in relation to expectations for successful executive leadership and performance in today’s dynamic health care environments.
You can discuss which elective course fits your career outlook best with an Academic Advisor.
Note: Tuition rates are subject to change and additional fees may vary by program. Please call at (844) 386-7323 for more information.
Per Credit Hour
- Tuition: $925.00
3 Credit Hours
- Tuition: $2,775.00
What's it like to earn this degree online?
- Study on your schedule
- The flexible anytime, anywhere approach to online learning at GW means that you can study and work on assignments when and where it’s convenient for you. Balance your personal and professional commitments. At GW online, you can advance your career without stopping it.
- Personalized learning
- Many of our online programs have a student-instructor ratio that’s lower than on-campus classes, making it easier to interact with fellow students and get personalized attention from your instructors. Plus, you have access to one-on-one tutoring to help ensure your success.
- The prestige of a GW degree
- Now you can earn a GW degree without relocating your life, giving you access to the distinguished connections and opportunities we provide. When you earn a degree from an online program at GW, you earn a degree from the George Washington University. Entrusted with its rights, privileges, and honors, you’ll join the ever-expanding GW alumni community who make the world a better place.
- Connect to campus from anywhere
- GW is your link to leading authorities in policy and health care in Washington, D.C. You’ll be able to research, collaborate, and discuss with classmates and instructors using online learning management systems. Engage with all the resources GW offers, including tutors, the writing center, career services, and libraries—all online.
- A dedicated advisor from day one
- Each GW online student is assigned an academic advisor who will support your journey to graduation. You’ll get help finding resources, guidance on scheduling classes, answers to your questions, and more. As an online learner at GW, you’re never alone.
- Round-the-clock tech support
- A late-night software malfunction won’t keep you from getting your assignment in on time. GW provides 24/7 technical support for our online students, ensuring you have complete access to what you need, when you need it.