Online Graduate Certificate Programs in Regulatory Affairs
While innovations and discoveries in science and technology mark progress in our civilization, they must be guaranteed to be safe for the public to use and consume. The role of regulatory affairs, specifically in healthcare, is to ensure that all products, including medicines and drugs, biologic products, medical devices, veterinary products, nutritional products, are safe and effective. Typically, a regulatory affairs professional is involved in the entire product development lifecycle, right from research and clinical trials, to manufacturing, labelling, and surveying the post market response to the product.
Students who wish to make a career in this highly rewarding field can opt for an online graduate certificate in regulatory affairs. An online certificate allows students to study at their pace, while continuing to work. This certificate provides them with an initial purview of the field, including regulatory affairs strategy, compliance, and clinical research. A number of universities offer students the option to transfer credits earned in this certificate to a master of science (MS) in regulatory affairs, which opens doors for higher paying jobs and opportunities.
An online graduate certificate in regulatory affairs can generally be completed in one to two years, and consists of nine to 18 credit-hours. The coursework explores topics such as regulation of medical devices and diagnostics, risk management for healthcare products, FDA regulatory affairs, and international regulatory affairs.
These certificates open up several opportunities for graduates such as that of compliance specialists, regulatory affairs associates, and pharmaceutical sales representatives. They can work in industries such as food safety, pharmaceuticals, and medical device manufacturing.
Read on to find detailed overviews of seven excellent online graduate certificates in regulatory affairs and three respected faculty members in the field.
Featured Online Graduate Certificates in Regulatory Affairs
George Washington University offers an online graduate certificate in regulatory affairs. This 100 percent online program does not require any campus visits and is ideal for working healthcare professionals entering the regulatory affairs field, or even seasoned professionals who wish to grow their skillset. The program faculty includes renowned professors with extensive real-world experience.
Admission requirements for the program include a bachelor’s degree, a grade point average of 3.0 or above, previous work experience (healthcare experience preferred), a written statement, a completed application, a current resume, two letters of recommendation, official transcripts from every college and university attended, and applicants who are not U.S. citizens are also required to submit official TOEFL, or PTE, or IELTS scores.
Comprising 18 credit-hours, the program has been developed by professionals working in the regulatory affairs department in government agencies, including the NIH and FDA. The coursework includes instruction in biostatistics for clinical and translational research, regulatory strategy in the development of drugs and biologics, global regulatory affairs, clinical research for regulatory affairs, and regulatory compliance. All credits earned in this certificate can be transferred to George Washington University’s MSHS in regulatory affairs program.
The program provides students with an understanding of regulatory affairs frameworks, teaches them how to examine medical devices, and also provides them with an overview of protocol development, assessment of regulatory submissions, and post-marketing surveillance. On successful completion of the program, graduates can take up roles such as regulatory affairs associate, compliance specialist, or regulatory affairs specialist.
- Location: Washington, D.C., United States
- Accreditation: Middle States Association of Colleges and Schools
- Expected Time to Completion: 24 months
- Estimated Tuition: $1,040 per credit-hour
The University of Southern California (USC) offers an online graduate certificate in regulatory and clinical affairs. This program is designed to provide specialized education for individuals interested in developing a systematic understanding of the U.S. regulatory system for medical products. It is structured especially for working professionals who wish to take courses in a convenient format. All courses in this program can either be taken online or in person.
The major admission requirements for the program include a bachelor’s degree with a minimum grade point average of 3.0 from an accredited college or university, two letters of recommendation, a current resume, a personal statement, and TOEFL or IELTS scores for international students. GRE scores are not required for admission to the certificate program.
Made up of 12 credit-hours, this certificate is designed to help students increase their knowledge in the prime areas of medical product development. The curriculum includes courses such as an introduction to medical product regulation, an introduction to risk management for healthcare products, regulation of medical devices and diagnostics, and structure and management of clinical trials.
The program provides students with a primer to medical product regulation, and trains them to take up roles in quality management and regulatory affairs in medical product development. At the end of the program, graduates can pursue opportunities in the pharmaceutical, food safety, and medical device industries.
- Location: Los Angeles, California
- Accreditation: Western Association of Schools and Colleges, the Senior College and University Commission (WSCUC)
- Expected Time to Completion: To be completed within five years
- Estimated Tuition: $1,960 per unit
The Massachusetts College of Pharmacy and Health Sciences offers an online graduate certificate in regulatory affairs. Students in this certificate program will build on their bachelor’s degree and gain advanced training in federal and international regulatory affairs. The program faculty includes renowned professors with extensive experience in devices, drugs, and policy.
In order to get accepted into the program, applicants must submit proof of completion of a bachelor’s degree from an accredited university, a minimum undergraduate grade point average of 3.0, and experience and employment in a research field.
Consisting of nine credit-hours, the program offers students with opportunities for advanced study in regulatory affairs, without committing them to a master’s degree program. Courses in the curriculum include international regulatory affairs, FDA and regulatory affairs, and an additional RAHP course.
Graduates of the program are prepared to advance their career by extending their expertise in regulatory affairs. They gain the scientific and practical knowledge needed to navigate the complex economic, political, business, and regulatory aspects of an ever-changing industry. They have access to world-class research facilities, leading biotech and pharmaceutical organizations, and hospitals. Also, graduates can transfer the credits earned in this program to the master of science in regulatory affairs and health policy program.
- Location: Boston, Massachusetts
- Accreditation: New England Commission of Higher Education
- Expected Time to Completion: 12 to 24 months
- Estimated Tuition: $990 per credit-hour
Northeastern University offers an online graduate certificate in biopharmaceutical domestic regulatory affairs. Designed for working professionals, this program provides students with a deep understanding of the inner workings of the biopharmaceutical industry and its product regulation and compliance requirements. The program faculty includes experienced and skilled industry leaders who are committed to the growth and engagement of their students.
Applicants to the program must submit a completed online application, a statement of purpose, a current professional resume, unofficial undergraduate transcripts, and English language proficiency proof for students whose primary language is not English.
The program comprises core courses such as an introduction to food and drug administration (FDA) pharmaceutical regulation, therapeutic product development: regulatory overview, and electives such as introduction to regulatory compliance and practice, an introduction to safety sciences, and fundamentals of CMC Regulations and methods.
The program prepares graduates to perform tasks such as assuring compliance, reducing costs, and improving techniques for measurement and acquisition. They get to develop a vast vocabulary of technical and regulatory terms and acronyms that are used distinctly by the FDA. The credits earned in this certificate can be applied to the master of science in regulatory affairs program.
- Location: Boston, Massachusetts
- Accreditation: New England Commission of Higher Education
- Expected Time to Completion: 12 months
- Estimated Tuition: $12K for the program
The University of Maryland School of Pharmacy offers an online graduate certificate program in regulatory science. This fully online program provides students with the skills and knowledge necessary for contributing to biologics, drug regulation, and pharmaceutical product life cycles. This online program is ideal for working professionals with bachelor’s degrees, who wish to work in regulatory science at government agencies or in industry. The program faculty includes dedicated professors who are nationally and internationally renowned for their work and have helped shape the field of biologic product development and regulation.
Admission requirements for the program include a completed online application form, a current resume or CV, one or three letters of recommendation, statement of goals, 300- to 500-word essay, an official transcript from each college or university currently attending or previously attended, and international students must submit TOEFL or IELTS scores. The Graduate Record Examination (GRE) general test is not required.
The curriculum for this program is made up of the first two courses of the MS in regulatory science program, comprising 12 credit-hours. These courses can also be applied towards the MS degree, if students wish to develop their knowledge and skills further. The two courses are as follows: drug, biologic, and device regulation, and drug and biologics discovery. This limited program is ideal for those who wish to earn a certificate in regulatory affairs without committing to a master’s program.
Students explore elements such as the legal framework for drug regulation, ethical issues in drug, biologic, and device development, and global regulatory guidance approaches. They learn about the basic concepts in drug chemistry and functional groups, and also how drugs can be metabolized and eliminated from the body.
- Location: Baltimore, Maryland
- Accreditation: Accreditation Council for Pharmacy Education (ACPE)
- Expected Time to Completion: Less than 12 months
- Estimated Tuition: $9,353 for in-state students, and $11,153 for out-of-state students
Drexel University offers an online graduate certificate in pharmaceutical and medical device regulatory compliance. Students who wish to develop knowledge of the ethical, legal, and regulatory aspects of the pharmaceutical and medical device industry can find this program valuable. The program aims to provide students with a comprehensive understanding of compliance and legal frameworks in the industry.
The major admission requirements for the program include a bachelor’s degree from a regionally accredited institution, a completed online application, official transcripts from all universities or colleges attended, a current resume, and TOEFL scores for students whose native language is not English.
Consisting of 15 credit-hours, courses in the program include compliance skills in auditing, investigation, and reporting; risk assessment and management; European union data privacy and protection; legal regulation of pharmaceutical and medical device research and development; and legal regulation of pharmaceutical and medical device sales and marketing practices.
The program can open up several opportunities for graduates. They can take up roles such as medical device sales representative, clinical research associate, medical device auditor, pharmaceutical compliance officer, regulatory compliance officer, and pharmaceutical sales representative.
- Location: Philadelphia, Pennsylvania
- Accreditation: Middle States Commission on Higher Education
- Expected Time to Completion: 12 months
- Estimated Tuition: $1,234 per credit-hour
San Diego State University offers an online advanced certificate in regulatory affairs. The Center for Regulatory Science at San Diego State University promotes excellence and career advancement opportunities for those in the biotechnology, pharmaceutical, and medical device industries. It helps them build a strong foundation in regulations, good manufacturing processes, and current laws mandated by U.S. and international regulatory agencies. All courses in this program are taught by instructors who are experts in the regulatory affairs field.
In order to get accepted into the program, applicants must have a bachelor’s degree from an accredited institution in the United States or its equivalent from a foreign institution, official transcripts for all universities and colleges attended, a current resume, among other requirements.
The program comprises 12 credit-hours and provides students with flexibility to balance their studies with their professional and personal commitments. The curriculum explores topics such as pharmaceutical, biotechnology, and medical device industries; food and drug law; current good manufacturing practices; and ethics for life science professionals. All credits earned in this program can be applied towards the MS in regulatory affairs degree.
Through the program, students are introduced to the biotechnology, medical device, and pharmaceutical industries, along with their activities such as product development, drug discovery, and chemical synthesis. They also learn about quality assurance, regulatory affairs, and control and marketing.
- Location: San Diego, California
- Accreditation: WASC Senior College and University Commission
- Expected Time to Completion: Six to 12 months
- Estimated Tuition: $950 per unit
Professors to Know in Graduate Certificates in Regulatory Affairs
Stephen F. Amato, PhD, MBA - Northeastern University
Dr. Stephen F. Amato heads the regulatory services department at Northeastern University. He has over 25 years of experience in the pharmaceutical, biotechnology, and medical device industries. His research efforts are focussed on the regulation of biomedical product commercialization; what drives the success of commercial biomedical products; and global reimbursement for biomedical products. Notably, he has published his work in prominent journals such as the Journal of Immunology and the Journal of Experimental Medicine. He holds his PhD and MBA from Boston College.
C. Benson Kuo, PhD - University of Southern California
Dr. C. Benson Kuo is an assistant professor in the Department of Regulatory and Quality Sciences. His research efforts are focussed on regulatory issues for innovative medical products and product safety in Asia.
Along with teaching, Dr. Kuo also serves as a consultant for innovation at USC, helping students and community members with regulatory compliance, strategic planning, and submission requirements. He is also a member of professional organizations such as the Regulatory Affairs Professional Society and the Orange County Regulatory Affairs Discussion Group. He holds his PhD from UC Riverside, his MS from University of Southern California and his BS from Tunghai University.
Melissa Tice, PhD - George Washington University
Dr. Melissa Tice serves as the director for the regulatory affairs program, as well as an assistant professor of clinical research and leadership at the George Washington University.
Prior to joining GW, she served as the vice president of global regulatory affairs at Immunomedics, Inc. She brings over 30 years of work experience in the field of science and regulatory affairs to the classroom. Her expertise lies in the development of regulatory strategies for drug development, as well as obtaining the approval of global health authorities for advances in the fields of oncology, cardiovascular disease, and vaccinations. She earned her BA in chemistry from the Douglass College at Rutgers University in New Jersey and her PhD in biological chemistry from the University of Pennsylvania.