Northeastern University assistant teaching professor David Mahoney shares his tips for breaking into the regulatory affairs field.
What is regulatory affairs? Finding a definition of the term can be an exceedingly difficult challenge. For example, the online Merriam-Webster dictionary doesn’t have an entry for the term among its more than 225,000 definitions.
Despite this lack of knowledge, the regulatory affairs field has a profound and direct impact on health and medical products, including drugs and biologics, as well as food consumed by people worldwide. These products, depending on the region, may be subject to strict regulations and approval processes.
Regulatory professionals in industry play a critical role in ensuring that their company’s products and processes meet such requirements in order to receive and maintain the necessary approvals and licenses. It’s an actively growing field that encompasses compliance with administrative regulations pertaining to food, health, and medical technology products.
Download Our Free Guide to Breaking into Regulatory Affairs
A guide to what you need to know to navigate the discipline and launch your regulatory career.
For anyone interested in regulatory affairs as a potential career, below is a look at the different roles available in the field, as well as the different job responsibilities and where you should go to stay up-to-date on emerging news about changing rules and regulations.
Roles and Work Settings within Regulatory Compliance and Affairs
There is no one role that can singularly define regulatory affairs. The scope of work extends beyond submissions to regulatory agencies. It also includes other activities of an organization, such as manufacturing, business, legal, research and development, marketing, as well as regulatory strategy, intelligence, and operations.
While 76 percent of regulatory affairs professionals are employed in industry, this is not the exclusive setting for those in the field. Other workplaces that employ regulatory professionals include government agencies, clinical research organizations, and hospitals, according to a 2016 report by the Regulatory Affairs Professional Society (RAPS).
Educational Backgrounds of Regulatory Affairs Professionals
Although regulatory affairs professionals most commonly hold a life sciences degree, a variety of other academic backgrounds exist. There are eight identified fields in addition to life sciences, according to the RAPS report. These include studies in:
- Clinical sciences/public health
- Regulatory affairs
- Liberal arts/social sciences
- Regulatory science
- Technical sciences
The Professional Experience Needed
More than 88 percent of regulatory professionals transitioned into regulatory affairs from a different field. The majority of individuals started in either research and development or manufacturing and quality. Other areas of experience include pharmacy and pharmacology, engineering, or healthcare and hospital administration.
Multi-Regional and International Job Responsibilities
Regulatory affairs work can be appealing to those who enjoy the opportunity to be involved in compliance matters extending across borders. International experience can serve as a valuable asset. The majority of regulatory affairs professionals in North America, Europe, and Asia have responsibilities that involve multi-regional and international regulatory compliance work, especially for roles within regulatory strategy, submissions, intelligence, and due diligence, according to the RAPS report.
Where to Learn More About Regulatory Affairs Organizations
There are several organizations available for people who are seeking to deepen their knowledge about the field of regulatory affairs. The Regulatory Affairs Professionals Society (RAPS) provides information and publications with access that varies depending on membership to RAPS. The Organization for Professionals in Regulatory Affairs (TOPRA) also provides resources for non-members as well as greater access rights for members.
Where to Learn More About Regulatory Agencies
In order to find out more about the types of regulations relevant for certain geographic regions, individuals should visit regulatory agencies’ websites. The Food and Drug Administration (FDA) primarily regulates the safety, efficacy, and security of drugs, biologics, medical devices, cosmetics, and most food products in the United States, as well as the manufacturing, marketing and distribution of tobacco products. The FDA is an agency of the United States Department of Health and Human Services.
The European Medicines Agency (EMA) is a European Union agency that scientifically evaluates, supervises and monitors medicines in the European Union.
Breaking into Regulatory Compliance
Regulatory affairs could be defined as an expanding field in which its professionals address compliance with administrative regulations pertaining to food, health, and medical technology products. While the scope of responsibilities involves submissions to regulatory agencies, it also encompasses related aspects, such as marketing, strategy, and business matters. The workplace settings may range from commercial industry to government positions.
Prior areas of practice held by an individual do not necessarily serve as a barrier to entry into the field, as the majority of current professionals transitioned from a different occupation. Often, individuals gain the opportunity to work in international matters. Most importantly, the field of regulatory affairs enables professionals the opportunity to be a valuable part of the process that brings food, drugs, and medical device products to consumers.