How To Become A Regulatory Affairs Specialist
The regulatory affairs industry oversees the development of foods, drugs, and medical products. Products are certified in meeting standards satisfactory for human use throughout the process of development, testing, manufacturing, marketing and distribution by specially-trained professionals.
Regulatory affairs specialists play a vital role in the well-being of the global population by monitoring the development and distribution of safe, healthy foods and technological advancements in medicine. Though regulatory affairs specialists work in a wide variety of disciplines such as public policy, health, science, economics, and law, they share the common goal of facilitating the saleability of products that are safe and effective for consumption and use by the public.
The majority of regulatory affairs specialists work in industries such as the pharmaceutical, biotechnology, food science, and medical device sectors. Others work as consultants in marketing, research, or law entities. Some are employed by hospitals, healthcare, and clinical research organizations, as well as in academic settings and government agencies.
The scope of activities of a regulatory affairs specialist varies depending upon the context in which one works. According to O*NET Online, specific tasks of individuals employed in this profession may include:
- Coordinating compliance documentation
- Examining product information
- Updating legal or regulatory knowledge
- Evaluating laws and regulations
- Explaining regulations, policies or procedures
- Overseeing business processes
- Obtaining authorization for activities
- Communicating with government agencies
- Maintaining data systems and databases
- Establishing organizational policies and guidelines
- Examining financial records and processes
- Preparing financial documents
- Training personnel
- Corresponding with customers
- Monitoring business indicators
- Analyzing environmental regulations
Not only is the market for regulatory specialists growing, but it is also changing as new technology becomes available, such as the move towards electronic formats for regulatory submissions (i.e., electronic common technical document or eCTD competency), blockchain technology, and social media marketing.
According to a U.S. Public Health Service and George Washington University survey, career flexibility and high earning potential were the top two reasons applicants stated for why they chose to pursue a master’s degree in regulatory affairs. Other reasons provided were the opportunity to make a difference, collaboration with other professionals, and the intellectual challenge of the field. Furthermore, students leaned towards online programs in regulatory affairs due to the flexibility, convenience, and in-depth feedback offered in this format.
This guide details the steps involved in becoming a regulatory affairs specialist.
A Step-by-Step Guide to Becoming a Regulatory Affairs Specialist
According to the UCI Division of Continuing Education, the main steps towards a career in regulatory affairs are:
- knowledge, skills, and experience in a subfield of the industry
- Learn the regulations that apply to the products in said subfield
- Learn how to apply the regulations to chosen subfield and its products
- Become a member of a regulatory organization
A detailed account of these basic steps follows.
Step 1: Earn a bachelor’s degree (4 years).
The minimum requirement for aspiring regulatory affairs specialists is a bachelor’s degree. Regulatory affairs workers come from a wide variety of fields. Many of them possess undergraduate degrees in engineering, clinical sciences, or public health. However, others come from business and economics degree programs or even a liberal arts background.
Choosing an undergraduate major towards a path in regulatory affairs requires some thought as to the specific sector in which one would like to serve. An individual planning to work as a regulatory affairs specialist within the pharmaceutical industry, for example, would be most competitive with a bachelor’s of science in pharmacy, pharmacology, pharmaceutical technology, chemistry, or biochemistry. However, professionals with foundational skills in biology, engineering, clinical sciences, management, and writing are also highly sought-after candidates for this diverse field.
Admissions requirements for most bachelor’s degrees include submitting high school transcripts with a proof of a competitive GPA (requirements vary according to school and major), SAT or ACT scores, and a personal essay.
Step 2: Get practical experience in the field (1 – 4 years).
The majority of current regulatory specialists came from another industry before finding their home in regulatory affairs, according to the Regulatory Affairs Professional Society (RAPS). However, 75 percent worked in fields closely related to regulations such as research and development, quality assurance and quality control, laboratory sciences, engineering, clinical research or pharmacy/pharmacology.
According to the UCI Division of Continuing Education, several possible paths across different fields can build a foundation of experience for those seeking a career in regulatory affairs:
- Biology: biological testing and research, development in a quality assurance lab
- Microbiology: microbiology testing and quality assurance lab work
- Chemistry: analytical testing, quality assurance and contract lab work
- Clinical research: clinical department positions for a research organization
- Computer science: circuit design, programming, and documentation
- Engineering: design, testing, quality, and medical device company positions
- Nursing: hospital and clinic work or clinical research for a biotech company
- English: medical writing in a clinical research setting
While relevant experience prepares professionals to enter the field and gain experience in regulatory affairs, a master’s degree provides the knowledge and skills necessary for leadership and upward mobility.
Step 3: Complete advanced coursework in regulatory affairs (1 – 5 years).
Though an undergraduate degree in an area closely related to the field lays the groundwork for a career in regulatory affairs, advanced knowledge of the industry and relevant experience are highly valued. Professionals with or without extensive work experience can gain both of these in a graduate or certificate program tailored to their areas of interest. Below are a few online graduate and certificate programs in regulatory affairs.
Arizona State University – Master’s of science in clinical research management and regulatory science
The focus of this 33-credit hour master’s degree is the regulation of clinical studies. The concentration is multidisciplinary and includes coursework in quality systems, medical device or pharmaceutical regulation, and regulatory writing techniques. Topics include the ethical aspects of research, fiscal and commercial practices of clinical research, and the management of clinical medical device, drug, and biological trials.
This flexible program is offered completely online, can be taken part-time, and includes a capstone clinical research project. Graduates are prepared for careers in biomedical or biotechnology regulatory affairs in as little as one year. GMAT or GRE scores are not required for admission; however, six months full-time experience in clinical research is a requirement.
Johns Hopkins University – Master’s of science in food safety regulation
This online program trains students to understand the legal ramifications of this sector of the industry. A hands-on approach is used to immerse students in the complex landscape of the production, labeling, and distribution of food. Courses are led by faculty from all over the world.
Completion of the ten-course program is required within five years but typically takes working professionals two to three years to complete. Full-time participants can graduate in one year. A bachelor’s degree in life sciences or engineering and a GPA of 3.0 or more is required to apply, as well as one semester of biochemistry and organic chemistry.
Johns Hopkins University – Master’s of science in regulatory science
Johns Hopkins also offers a master’s in regulatory science that prepares students to lead regulatory efforts in biotechnology across academic, government, and industrial settings. This program is the same length as the food safety degree. However, students may choose a specialization across a wide variety of advanced regulatory courses by taking three electives. All students in this program complete a practicum course before graduating and leave with a strong foundation in biotech product development and manufacturing, lab skills, and clinical practices. A bachelor’s degree in life sciences or engineering and a GPA of 3.0 or more is required to be eligible, as well as one semester of biochemistry and cell biology.
George Washington State University – Master’s in health services and regulatory affairs
GW offers three online programs for aspiring regulatory affairs specialists: a healthcare MBA with a regulatory affairs graduate certificate, a master’s in health services and regulatory affairs, and a graduate certificate in regulatory affairs.
In addition to the traditional business and healthcare management classes, specialized courses in the healthcare MBA are offered through the GW school of medicine and health sciences including biostatistics translational research, regulatory device diagnostics, and regulatory affairs compliance. Graduates of this 73.5-credit degree program focus on bringing new products to patients while ensuring safety, quality, and efficacy.
Graduates of the 36-credit healthcare MSHS in regulatory affairs are prepared to manage the most important elements of the clinical research regulatory process. The focus of this program is on global health and cost control outcomes. Courses include clinical research for regulatory affairs, issues and trends in health systems, and regulatory strategies.
An 18-credit graduate certificate in regulatory affairs can be taken on its own or applied towards the MSHS program. This certificate curriculum was developed through collaborations with the Food and Drug Administration (FDA) and regulatory affairs professionals.
All of these GW programs require some work experience in healthcare or clinical institutions, with a three-year minimum requirement for the healthcare MBA. A GMAT waiver is available for qualified MBA applicants and not required at all for the MSHS or graduate certificate program.
The University of Cincinnati – Graduate certificate in health care policy and regulation
This 12-credit graduate certificate in health care policy and regulation can be completed in as little as 18 months. Courses include health systems administration, health policy I/II, and an elective class. Students evaluate the impact of policies and programs on patient populations with the goal of improving patient outcomes.
Step 4: Obtain certification (several weeks or months).
A career in regulatory affairs requires credentialing. Certifications beyond an undergraduate or graduate degree or a certificate program benefit both employees and employers. They allow professionals to stay up-to-date on changes in the field, add to their knowledge base, and increase their versatility. Furthermore, professional credentials and certifications enable employers to easily gauge a candidate’s knowledge base. They also demonstrate an individual’s area of expertise and commitment to the profession. Here are some certification resources:
Working professionals with three to five years of regulatory experience are eligible to take the regulatory affairs certification exam through RAPS—the only credential for regulatory affairs specialists in the healthcare product industry. Four exams (US, EU, CAN, GLOBAL) test candidates on their ability to analyze the lifecycle of a product using regulatory knowledge and critical thinking skills. International standards and guidelines for healthcare products are tested on the RAC global exam.
ACMA administers the board-certified medical affairs specialist program (BCMAS), which is a self-paced, online program for professionals with doctoral or master’s degrees seeking CME credits. Upon completion, candidates may take a board examination. This credential must be renewed by retaking the board exam or completing 20 additional hours of continuing education every five years.
ASQ offers certification in many areas of the regulatory affairs industry, such as biomedical and food safety auditor, pharmaceutical GMP professional, and software quality engineer, among others. Additionally, the FDA recommends membership in the ASQ to access benefits like regular meetings, publications, and leadership opportunities, as well as professional development through conferences, seminars, and other activities through the many local chapters of the organization. Regional ASQ centers currently operate globally in North Asia and South Asia, Latin America, the Middle East, and Africa with a commitment to educating on the requirements for product quality.
Helpful Resources for Aspiring Regulatory Affairs Specialists
As a final note, the below list of professional organizations may help for those looking to enter this career field:
- Regulatory Affairs Professionals Society (RAPS)
- NIH National Center for Complementary and Integrative Health, Office of Clinical and Regulatory Affairs (NCCIH/OCRA)
- The OrganiZation for Professionals in Regulatory Affairs (TOPRA)
- Orange County Regulatory Affairs Discussion Group (OCRA)
- US Food and Drug Administration, Office of Training Education and Development (OTED)