Is becoming a regulatory affairs manager right for me?

The first step to choosing a career is to make sure you are actually willing to commit to pursuing the career. You don’t want to waste your time doing something you don’t want to do. If you’re new here, you should read about:

What do regulator affairs managers do?

Still unsure if becoming a regulatory affairs manager is the right career path? to find out if this career is right for you. Perhaps you are well-suited to become a regulatory affairs manager or another similar career!

Described by our users as being “shockingly accurate”, you might discover careers you haven’t thought of before.

How to become a Regulatory Affairs Manager

Bachelor’s Degree
A bachelor’s degree is the minimum requirement to work in the regulatory affairs sector. Most regulatory affairs managers hold an undergrad degree that is directly related to the field in which they work. For example, overseeing regulatory compliance in the pharmaceutical industry typically calls for a pharmaceutical science or pharmacy degree.

The following degrees are quite prevalent among regulatory affairs managers, because they are relevant to fields such as life sciences, pharmacy, engineering, law, and financial services, in which safety and efficacy compliance is particularly important:

Industry Experience
Employers of regulatory affairs managers generally require several years of industry experience in areas such as research and development, quality assurance, or regulatory affairs. It is therefore common for aspiring regulatory affairs managers to begin their careers in internships or entry-level regulatory roles such as regulatory affairs associate or specialist, where they can gain experience in the industry and function in which they wish to specialize.

Membership in Professional Organizations / Certification
As the field of regulatory affairs management is constantly evolving, it is important to stay up to date with the latest technologies and industry developments. The following organizations can provide access to professional events and training opportunities, continuing education, and industry research and resources, as well as a network of like-minded professionals working in the field. Many of these organizations administer voluntary certifications relevant to the regulatory affairs industry, which typically involve passing an exam and meeting specific education and experience requirements. Some companies may stipulate one or more of these certifications as a condition of employment, particularly in more senior roles.

  • Regulatory Affairs Professionals Society (RAPS) – This is a global organization that provides education, training, and certification for regulatory professionals. RAPS offers the Regulatory Affairs Certification (RAC).
  • Institute of Certified Professional Managers (ICPM) – ICPM confers the Certified Manager of Regulatory Affairs (CMRA) certification, designed for professionals who manage regulatory affairs departments or teams.
  • American Bankers Association (ABA) – This association administers the Certified Regulatory Compliance Manager (CRCM) certification, designed for professionals who work in regulatory compliance in the banking industry.
  • American Society for Quality (ASQ) – ASQ offers the Certified Quality Auditor (CQA) certification, designed for professionals who audit regulatory compliance and quality systems.
  • Medical Affairs Professional Society (MAPS) – This organization confers the Certified Professional in Medical Affairs (CPMA) certification, designed for professionals who work in medical affairs and have a strong understanding of regulatory requirements.
  • Society of Quality Assurance (SQA) – SQA promotes quality assurance in regulated industries and administers the Registered Quality Assurance Professional (RQAP) certification.
  • Association of Regulatory Affairs Professionals (ARAP) – This organization supports and promotes the professional development of regulatory professionals.
  • Drug Information Association (DIA) – This organization provides education, training, and networking opportunities for professionals in the pharmaceutical, biotechnology, and medical device industries.
  • International Society for Pharmaceutical Engineering (ISPE) – ISPE supports the pharmaceutical manufacturing industry and provides training, education, and networking opportunities.
  • Parenteral Drug Association (PDA) – This association is a global provider of science, technology, and regulatory information for the pharmaceutical and biopharmaceutical communities. Parenteral drugs are administered by routes other then the digestive tract; examples are injections and implanted drug products that allow direct administration of drug substances into blood vessels, tissues, organs, or lesions.

Graduate Degree
Some companies may require a master’s or doctoral degree in a discipline applicable to their business.