Champion Quality Health care Products

Modality: 100% online via asynchronous courses; no visits to campus required.

Program completion: 24 months

Cost/Credit Hour: $980

Students of the GW 100% online programs in Regulatory Affairs will graduate with the experience and competence to:

• Provide strategic direction and integrate business needs in matters of regulatory science and affairs.
• Lead and collaborate with functions and stakeholders for the effective development of medical products.
• Understand the philosophies and roles of the domestic and international regulatory agencies that oversee drug, biologic, device, and diagnostic development.
• Evaluate the scientific and economic value of bringing new health care products into the global market.

Designed for working professionals, the MSHS in Regulatory Affairs program focuses on regulatory strategy, compliance, legal and ethical issues. Examine and develop processes for product development while balancing business demands and regulatory standards. This 100% online program prepares you to manage the key elements of the regulatory process while helping drive patient-centered innovation in health care.

Career Outlook

• Nearly a third (31.6%) of organizations increased their regulatory staff in 2017¹
• Almost half (47.5%) expect their employers to hire additional regulatory staff in 2018–19¹

Regulatory affairs professionals play a pivotal role in developing, approving, and delivering key medical advancements in today’s dynamic global health care industry.

Meet the growing demand for qualified professionals who can transform regulatory oversight while you prepare to fill a variety of roles, including:

• Regulatory Affairs Specialist: $67,315 avg. salary²
• Regulatory Affairs Manager: $101,076 avg. salary³
• Senior Chemistry, Manufacturing, and Controls (CMC) Manager: $102,439 avg. salary⁴
• Technical Engineer: $64,453 avg. salary⁵
• Medical Affairs Associate: $80,000 avg. salary⁶
• Quality Assurance Engineer: $69,228 avg. salary⁷

Sources:

^{1 Regulatory Affairs Professionals Society (2018 October). 2018 Global Compensation & Scope of Practice Report for the Regulatory Profession. Retrieved February 21, 2020, from raps.org/news-and-articles/news-articles/2018/10/raps-releases-results-of-compensation-survey-of-re}

^{2 Payscale (2020 February 11). Regulatory Affairs Specialist. Retrieved February 21, 2020, from payscale.com/research/US/Job=Regulatory_Affairs_Specialist/Salary}

^{3 Payscale (2020 February 11). Regulatory Affairs Manager. Retrieved February 21, 2020, from payscale.com/research/US/Job=Regulatory_Affairs_Manager/Salary}

^{4 Payscale (2020 January 29) Senior Chemistry and Manufacturing Controls (CMC) Project Manager. Retrieved February 21, 2020, from payscale.com/research/US/Job=Senior_Chemistry_and_Manufacturing_Controls_(CMC)_Project_Manager/Salary}

^{5 Payscale (2020 February 11). Technical Engineer. Retrieved February 11, 2020, from payscale.com/research/US/Job=Technical_Engineer/Salary}

^{6 Payscale (2020 January 7). Medical Affairs Associate). Retrieved February 11, 2020, from payscale.com/research/US/Job=Medical_Affairs_Associate/Salary}

^{7 Payscale (2020 February 12). Quality Assurance (QA) Engineer. Retrieved February 11, 2021, from payscale.com/research/US/Job=Quality_Assurance_(QA)_Engineer/Salary}

Please complete the form on this page to receive free, no-obligation program details now.

Modality: 100% online, no visits to campus required
Tuition: $980 per credit hour
Program Completion: 12 months

Program Highlights:

• 100% online, no visits to campus required
• The program requires 12 total credits and can be finished in 12 months
• Developed by regulatory affairs professionals working in governmental agencies such as the FDA and NIH
• All credits can be transferred into the MSHS in Regulatory Affairs program

The online Graduate Certificate in Regulatory Affairs program integrates global regulatory strategy across the curriculum to equip graduates as business leaders in regulatory strategy locally and abroad. Upon completion of the graduate certificate, students have the opportunity to transfer all 12 credits into the MSHS in Regulatory Affairs program.

Program Outcomes

• Demonstrate knowledge of development and evaluation of global regulatory strategies that support drug and biologic product development.
• Examine the regulation of medical devices through an epidemiological lens
• Understand topics such as protocol development, study design, post-marketing surveillance, evaluation, and assessment of regulatory submissions

Please complete the form on this page to receive free, no-obligation program details now.

Modality: 100% online, no visits to campus required.
Undergraduate tuition rate: $635 per credit hour.
Graduate tuition rate: $1,040 per credit hour.*

* Nine credits of the MSHS in Regulatory Affairs are completed in the undergraduate portion of the program and charged at the undergraduate per credit cost of $635.

Program Highlights

• 100% online, no campus visits are required
• Both degrees are conferred sequentially
• Transfer up to 60 total credits from a regionally accredited institution into the undergraduate portion of the program
• Nine credits of the MSHS in Regulatory Affairs are completed in the undergraduate portion of the program and charged at the undergraduate per credit cost

Our multi-level, dual-degree learning option provides you a seamless way to earn your BSHS in Clinical Research Administration and an MSHS in Regulatory Affairs through an accelerated format, allowing you to earn your BSHS and MSHS in less time by combining the work toward both degrees.

Program Outcomes

• Apply Good Clinical Practice (GCP) regulations to ensure clinical trials meet sponsor needs, investigator goals, and regulatory standards.
• Understand pre- and post-market requirements for medical products as governed by domestic and international law.
• Develop and manage ethical clinical trials that address cultural considerations and meet commercial needs.
• Employ business principles and lead strategic decision-making in a variety of health care roles.

Please complete the form on this page to receive free, no-obligation program details now.

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.