I have spent the last 25 years working in the pharmaceutical industry and I can’t even begin to recall the number of times I have been asked “How did you get a job in Regulatory?” Most who currently work in regulatory would probably agree that a career in regulatory affairs was not their planned destination when accepting their diploma at their college or university commencement. It was most likely an unexpected opportunity that found them, or it was an area of interest that one became aware of while working in technical research or a production environment. I dare to say there really is anyone who, as a child, ever said “I want to work in regulatory affairs when I grow up.” In my experience, most individuals transfer into regulatory affairs from another department within their company.
Regulatory Affairs is a vast area covering many aspects within the lifecycle of a drug product. Typically, it involves supporting the drug development process including animal and human studies in addition to support of currently marketed products all the way to the end of the lifecycle or delisting of product. In addition, there are more specialized areas of regulatory affairs that require different skill sets such as devices, large molecules, generics, and combination products.
Available academic programs can focus on clinical, biotechnology, small molecule, and health law just to name a few. Regulations and filing requirements vary across the specialized areas which require specific knowledge and experience that can be difficult to acquire. If one is lucky enough to work on specific projects and gain experience supporting health authority filings, transitioning into a regulatory affairs career can be an uncomplicated process. However, those that do not receive such opportunities are typically looking for alternate pathways into regulatory affairs. Many times, career opportunities in quality assurance arise for those with solid technical backgrounds and those individuals are also looking for additional educational opportunities in the pharmaceutical regulatory environment. Often the regulatory environment is partnered with quality assurance and many programs offer courses covering both topics.
This article is intended for utilization as a reference for those considering opportunities for formalized educational pathways to regulatory affairs and quality assurance degrees.
There are many different schools and programs that can be tailored to meet one’s educational needs (Table 1). Programs vary from traditional in-classroom courses to online courses with academic institutions located across the United States and in Europe. Courses may be taken as part of an undergraduate or graduate program or even as part of a certificate program. In addition, professional organizations provide certification programs related to regulatory affairs and quality assurance, which will not be covered in this article.
Consideration should be given to the following when choosing an academic program.
- Geographical Location: Location may or may not influence one’s decision in choosing a program. Typically, location would only come into consideration if one was interested in attending classes that offered traditional delivery of classes on campus.
- Class Schedule: When classes are held can be critical. Classes can be offered during the traditional week day and on weekends and offered during the day or at night. Many courses offered as part of undergraduate degrees are offered during weekday business hours making them inaccessible to working professionals. Most classes that are part of a graduate degree or certificate program are offered during the evenings and weekends to accommodate all potential students.
- Delivery Mode: An alternate approach to the traditional classroom is online delivery. Online courses have gained a great amount of popularity in recent years. There are advantages and disadvantages that should be considered. While many working professionals value the flexibility of an online class, one does need to consider if classes are offered during evening hours or on weekends. Classes can be offered live or synchronously or can be recorded and offered asynchronously. While asynchronous classes offer flexibility regarding scheduling, one must be a self-disciplined learner and realize there is limited or no live interaction with the instructor or other classmates. Some asynchronous classes offer only slides for the student to review and study on their own while other classes may offer recorded lectures given by the instructor with accompanying slides. On the other hand, synchronous or live classes meet at a preset time using online meeting software. These classes allow for live lectures, visual observation of the instructor and other classmates, live question and answer sessions, virtual working groups and invaluable interactions with the instructor and classmates. In my opinion, synchronous class delivery is most beneficial when considering online classes
- Faculty Experience: Faculty member experience is another factor to consider when choosing a program. Programs may use full time faculty members that have spent their entire professional careers at academic institutions while other programs also use adjunct faculty members who hold full time positions within the pharmaceutical industry and health authorities. The faculty member’s past and current experience within pharmaceutical industry can be an invaluable addition to the learning environment as examples of regulatory strategy and problem solving are shared from their professional experience.
- Laboratory/Hands on Practice: One’s desire for hands on experience may also influence the choice of a school. Some schools offer hands on laboratory experience or field trips to manufacturing and testing facilities allowing one to experience how to manufacture product or visit a GMP manufacturing facility or testing laboratory. The geographical location of academic institution will also determine if such visits are possible.
- Program Options: Programs offer a variety of academic options. One can earn a certificate, master’s degree or ultimately a professional doctorate degree. One institution has been identified that offers a Doctor of Philosophy. Most graduate students earn a master’s degree which very much sets one apart from other applicants in the job market.
- Focus Area: Finally, a major consideration would be the focus area of the program. There are many diverse areas of study under the umbrella of regulatory affairs and quality assurance. Some programs offer more generalized areas of study while others hone in on a specific topic (Table 2).
Whether one is looking to pursue education with the goal of career advancement or just interested in taking a few courses to expand one’s regulatory knowledge, there are many options to choose from. Education is one thing that can never be taken from you. The knowledge and contacts gained during the academic journey can be invaluable to one’s future success.
Table 1: Academic institutions offering regulatory affairs programs leading to various certificates and degrees.
Table 2: Academic Areas of Focus for Certificates and Master’s Degree