How to Become a Regulatory Affairs Specialist

The regulatory affairs industry oversees the development of foods, drugs, and medical products. Specially trained professionals ensure that products meet human use standards throughout development, testing, manufacturing, marketing, and distribution.

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 safe and effective products for consumption and use by the public.

Most regulatory affairs specialists work in 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 ONET Online (2024), 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

The market for regulatory specialists is 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.

Career flexibility and high earning potential were the top two reasons applicants pursue a master’s degree in regulatory affairs. Other reasons include the opportunity to make a difference, collaboration with other professionals, and the intellectual challenge of the field. Furthermore, students lean 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.

The main steps toward 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 the 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 a liberal arts background.

Choosing an undergraduate major toward a path in regulatory affairs requires thinking about the specific sector one would like to serve. For example, an individual planning to work as a regulatory affairs specialist within the pharmaceutical industry would be most competitive with a bachelor of science in pharmacy, pharmacology, pharmaceutical technology, chemistry, or biochemistry. However, professionals with foundational skills in biology, engineering, clinical sciences, management, and writing are 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. However, several professionals have 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.

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

Step 3: Earn a master’s degree (two years).

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.

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 is 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 – Masters 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, providing 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 multidisciplinary concentration 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 clinical research experience is required.

This flexible program is offered completely online, can be taken part-time, and includes a capstone clinical research project. Graduates are prepared for biomedical or biotechnology regulatory affairs careers in as little as one year. They can be 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 to assess products 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 product quality, performance, and safety.

• Location: Phoenix, AZ
• Accreditation: Commission on Accreditation of Allied Health Education Programs (CAAHEP); Higher Learning Commission (HLC)
• Expected Time to Completion: 24 months

Johns Hopkins University – Master of science in biotechnology with a concentration in regulatory affairs

Through the fully online master of science program in biotechnology with a concentration in regulatory affairs offered by Johns Hopkins University’s Krieger School of Arts & Sciences, students will complete the same four required core courses as the standard MS in biotechnology degree. Additionally, they will complete four areas of concentration courses and two elective courses.

Completing the ten-course program is required within five years but typically takes working professionals two to three years. Full-time participants can graduate in one year. To apply, you must have a bachelor’s degree in life sciences or engineering and a GPA of 3.0 or more, as well as one semester of biochemistry and organic chemistry.

The 40-credit curriculum includes core courses such as advanced cell biology, cellular signal transduction, emerging applications in biotechnology, and the biotechnology enterprise.

Courses in the regulatory affairs concentration include clinical development of drugs and biologics; biological processes in regulatory affairs; international regulatory affairs; ethical, legal, and regulatory aspects of the biotechnology enterprise; and independent studies in regulatory science.

Graduates can take up roles such as regulatory specialists, managers, directors, or consultants.

• Location: Baltimore, MD
• Accreditation: Middle States Commission on Higher Education (MSCHE)
• Expected Time to Completion: 12 to 36 months

Johns Hopkins University – Master 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 previous 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.

The 40-credit program includes courses such as introduction to regulatory affairs, food and drug law, translational biotechnology, international regulatory affairs, and clinical development of drugs and biologics.

• Location: Baltimore, MD
• Accreditation: Middle States Commission on Higher Education (MSCHE)
• Expected Time to Completion: 20 to 36 months

George Washington University – Master of science in health sciences (MSHS) in regulatory affairs and clinical research leadership

The online MSHS in regulatory affairs and clinical research leadership program offered by George Washington University’s (GW) School of Medicine and Health Sciences (SMHS) was developed in partnership with regulatory affairs professionals working in the industry and governmental agencies such as the NIH and FDA. The fully online program does not require 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. This program focuses on global health and cost control outcomes.

Courses include an introduction to global regulatory affairs and clinical research, regulatory strategy in the development of therapeutics, international regulatory affairs and clinical research, leadership in regulatory affairs, regulatory strategy in the development of devices and diagnostics, and clinical research for regulatory affairs.

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.

Upon completing 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 a 12-credit graduate certificate in regulatory affairs that can be taken independently or applied to the MSHS program.

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

• Location: Washington, DC
• Accreditation: Middle States Commission on Higher Education (MSCHE)
• Expected Time to Completion: MSHS and certificate (12 to 24 months); Dual degree (four to five years)

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

The University of Cincinnati’s College of Allied Health Sciences and the Lindner College of Business jointly deliver an online healthcare policy and regulation graduate certificate. This graduate certificate gives students an understanding of how the law applies to the healthcare system while equipping them with the knowledge and skills to manage, regulate, and organize healthcare services.

This 12-credit graduate health care policy and regulation certificate 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 as human resources managers, public health administrators, planning and development managers, information systems managers, health educators, and health care attorneys.

• Location: Cincinnati, OH
• Accreditation: Higher Learning Commission (HLC)
• Expected Time to Completion: 18 months

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 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 gauge a candidate’s knowledge base easily. 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. Intended for professionals employed in regulatory agencies, consultancies, industry, and other settings involved with the regulation of healthcare products, this certification tests expertise in two sectors: medical devices and pharmaceuticals.

Candidates may choose to take the RAC Devices exam or the RAC Drugs exam. The RAC program will recognize all candidates passing this exam equally and will make them eligible to put ‘RAC’ after their name.

Accreditation Council for Medical Affairs

ACMA administers the board-certified medical affairs specialist program (BCMAS), 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 food safety and quality auditor, pharmaceutical GMP professional, and software quality engineer. 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.

As a final note, the below list of professional organizations may help 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)