How to Become a Regulatory Affairs Specialist

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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 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:

  • Gain 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 (four 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 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 (one to four 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 (one to five 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

Arizona State University offers an online MS in clinical research management with a concentration in regulatory science provides students with an education that focuses on managing trials and conducting clinical research, with a special focus on the regulatory aspect of research.

The focus of this 33-credit master’s degree is the regulation of clinical studies. The concentration is multidisciplinary and includes coursework in medical device development and regulation, quality assurance and clinical research, pharmaceutical safety and risk management, technical writing for the regulatory professional, and clinical research data management and technology implementation.

Admission requirements include a bachelor’s or master’s degree with a minimum cumulative grade point average of 3.0, Official transcripts, Three references, a curriculum vitae, and proof of English proficiency. GMAT or GRE scores are not required for admission; however, six months of full-time experience in clinical research is a requirement.

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. They will be able to take up roles such as quality control specialists, regulatory affairs managers, regulatory affairs specialists, and clinical research associates.

ASU also offers an online 33-credit MS in regulatory science preparing students in assessing those products that are typically overseen by several agencies and corporations, including the FDA (Food and Drug Administration). Students in this program will learn about the various standards and methods of approaching the quality, performance, and safety of products.

  • Location: Phoenix, AZ
  • Accreditation: Commission on Accreditation of Allied Health Education Programs; Higher Learning Commission (HLC)
  • Expected Time to Completion: 24 months
  • Estimated Tuition: MS in clinical research management – regulatory science ($870 per credit); MS in regulatory science ($620 per credit)

Johns Hopkins University – Master’s of science in food safety regulation

Through the fully online master of science in food safety regulation program offered by Johns Hopkins University’s Krieger School of Arts & Sciences, students will learn to examine the roles of harvesting and food production, pest control, transport and storage, food processing, handling, and advertising.

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.

Made up of 40 credits, the curriculum includes courses such as introduction to food safety, food microbiology, food toxicology, food safety audits & surveillance, regulation of good food production practices, and food labeling and packaging regulations.

Graduates will be able to take up roles such as regulatory specialists, managers, directors, or consultants.

  • Location: Washington, DC
  • Accreditation: Middle States Commission on Higher Education
  • Expected Time to Completion: 20 to 36 months
  • Estimated Tuition: $4,815 per course

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. 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.

Comprising 40 credits, the program includes courses such as introduction to regulatory affairs, food and drug law, biological processes in regulatory affairs, translational biotechnology, and clinical development of drugs and biologics.

  • Location: Washington, DC
  • Accreditation: Middle States Commission on Higher Education
  • Expected Time to Completion: 20 to 36 months
  • Estimated Tuition: $4,815 per course

George Washington University – Master’s of science in health sciences (MSHS) in regulatory affairs

The online MSHS in regulatory affairs program offered by George Washington University’s (GW) School of Medicine and Health Sciences (SMHS) was developed in partnership with professionals in regulatory affairs working in the industry and governmental agencies such as the NIH and FDA. The fully online program does not require any campus visits.

Graduates of the 36-credit healthcare MSHS in regulatory affairs program 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 issues and trends in health systems, biostatistics translational research, epidemiology translational research, introduction to global regulatory affairs, regulatory drug biologics, and regulatory device diagnostics, among others.

Applicants to the program must have a bachelor’s degree from a regionally accredited institution, a grade point average of 3.0, a current resume, a personal statement, two letters of recommendation, and a completed online application.

On successful completion of the program, graduates can take up roles such as regulatory affairs specialists, regulatory affairs managers, technical engineers, medical affairs associates, and quality assurance engineers.

GW also offers an 18-credit graduate certificate in regulatory affairs that can be taken on its own or applied towards the MSHS program.

Apart from these, George Washington University also offers an 87-credit dual degree: BSHS in clinical research administration to MSHS in regulatory affairs allowing students to earn their BSHS and MSHS in less time by combining the coursework for both degrees.

  • Location: Washington, DC
  • Accreditation: Middle States Association of Colleges and Schools
  • Expected Time to Completion: MSHS and certificate (24 months); Dual degree (36 months)
  • Estimated Tuition: MSHS and certificate ($980 per credit); dual degree ($728 per credit)

The University of Cincinnati – Graduate certificate in health care policy and regulation

An online graduate certificate in health care policy and regulation is jointly delivered by the University of Cincinnati’s College of Allied Health Sciences and the Lindner College of Business. This graduate certificate provides students with an understanding of how the law applies to the health care system while also equipping them with the knowledge and skills of managing, regulating, and organizing the delivery of health care services.

This 12-credit graduate certificate in health care policy and regulation can be completed in as little as 18 months. Courses include health systems management: organization and delivery, health policy: health policy & regulation, and health policy: legal and ethical issues. Students evaluate the impact of policies and programs on patient populations to improve patient outcomes.

To get accepted into the program, applicants must have a bachelor’s degree from a regionally accredited institution, official transcripts of all graduate and undergraduate work, a minimum cumulative grade point average of 3.0, a letter of intent, a current resume, and TOEFL scores for international applicants.

At the end of the program, graduates can pursue opportunities such as a human resources manager, public health administrator, planning and development manager, information systems manager, health educator, and health care attorney.

  • Location: Cincinnati, OH
  • Accreditation: Higher Learning Commission (HLC)
  • Expected Time to Completion: 18 months
  • Estimated Tuition: Resident ($754 per credit); non-resident ($769 per credit)

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:

Regulatory Affairs Professionals Society

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.

Accreditation Council for Medical Affairs

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.

American Society for Quality

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)

Featured Regulatory Affairs Programs

Arizona State University
Arizona State University

Clinical Research Management - Regulatory Science (MS)

Corporate and Health Care Compliance (MLS)

Food Safety and Protection (Graduate Certificate)

Johns Hopkins University - Advanced Academic Programs
Johns Hopkins University - Advanced Academic Programs

MS Food Safety Regulation

MS Regulatory Science

The George Washington University School of Medicine & Health Sciences
The George Washington University School of Medicine & Health Sciences

BSHS in Clinical Research Administration/MSHS in Regulatory Affairs

Graduate Certificate in Regulatory Affairs

MSHS in Regulatory Affairs

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Cevia Yellin
Cevia Yellin
Writer

Cevia Yellin is a freelance writer based in Eugene, Oregon. She studied English and French literature as an undergraduate. After serving two years as an AmeriCorps volunteer, she earned her master of arts in teaching English to speakers of other languages. Cevia's travels and experiences working with students of diverse linguistic and cultural backgrounds have contributed to her interest in the forces that shape identity. She grew up on the edge of Philadelphia, where her mom still lives in her childhood home.