Recruiting for Regulatory - Are We Doing Enough?

When was the last time someone asked why you chose to work in regulatory? More specifically, what would be your elevator pitch if a recent graduate or a soon-to-graduate student asked you about your career in regulatory? Would you start with the specific area in which you work (e.g., commercial regulatory; chemistry, manufacturing and controls; clinical trial authorization; regulatory strategy), describe your primary customer (the branch of the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), etc.) or speak to relevant attributes necessary to be successful (attention to detail, good communication skills). Perhaps, like me, you would begin by describing how you were first exposed to the profession.

Regardless of how you approach the question, it is important to recognize that you are most likely the student's first and only point of contact with the regulatory world. There are few opportunities for students to gain insight into regulatory roles. Even if students are aware of such roles, they usually have only a very general understanding about the responsibilities associated with them. I consider myself lucky because I had multiple industry opportunities in pharmacy school. This, in part, is due to the fact that I attended a school in the middle of a major pharmaceutical hub-seven of the 10 largest pharmaceutical companies are within a 40-mile radius. Many students do not have this luxury and are fortunate if they have any industry experience during their schooling.

In the end, the regulatory field loses the most because many bright graduate school attendees end up choosing better-known industry careers. If the regulatory profession wants to attract a strong talent pool, it must begin to increase the amount of outreach it provides students so they have a comprehensive understanding of the key differences between each regulatory department.

My Introduction to Regulatory

As a pharmacy (PharmD) student, I assumed regulatory was just another research and development role requiring scientific knowledge and was interchangeable with working in a laboratory as a scientist. A career in regulatory was not even a consideration until I shadowed a commercial regulatory reviewer in a promotional review meeting during my advanced pharmacy practice experience (APPE) rotation at Novartis in my sixth year of pharmacy school. Embedded within pharmacy curriculums are mandatory rotations geared toward providing students with the opportunity to apply their clinical knowledge. Students typically are required to complete six to eight rotations during their last year of pharmacy school. A large percentage of PharmD students use their APPE rotations to explore various career options. Unfortunately, because certain rotations occur later in the year than others, exposure to a field such as regulatory during the latter portion of the year may prove too late for the student to consider a career switch. That easily could have been my fate had it not been for that one rotation that, by sheer happenstance, occurred during the beginning of my rotation year.

Now, two years removed from pharmacy school and in a position as a postdoctoral fellow where I interact with many pharmacy students, I am asked continuously about different roles within the pharmaceutical industry and what experience is necessary to qualify for them. I am surprised to find students consistently categorize regulatory into two specific profiles: an opportunity to work with regulatory agencies to approve healthcare products or a stodgy office job predominantly entailing paperwork. Furthermore, when I ask on which department within regulatory they would like more information, I often am greeted by confused faces. Students wrongly assume regulatory is one large department and do not realize it is a network of various departments touching all phases of healthcare product development.

Survey on Student Perceptions

I was curious to see whether the opinions I kept encountering were based on actual experience or insufficient exposure to regulatory, so I created a short survey for students. If the cause of students' misconceptions was insufficient exposure, then a solution could be additional outreach conducted on behalf of healthcare products companies. At least, that was my assumption when I began the survey.

There were two overarching goals for the survey: 1) to gain a better understanding of how pharmacy and regulatory students in the US view regulatory; and 2) to determine whether there is sufficient outreach to PharmD students regarding regulatory careers. The survey was distributed via email to 171 pharmacy and regulatory students in the US who had responded previously to a nationwide email on fellowship opportunities distributed by a network of pharmacy school deans.

The criteria for participation in the survey were current enrollment in pharmacy school or a regulatory graduate program, or recent graduation from either. Participants were asked four main questions: how they first were introduced to regulatory; if they had academic or professional regulatory experience; how much they knew about regulatory; and whether there was a need for more outreach.

After two weeks, the predetermined duration of the survey, there were 28 responses. As suspected, a majority of respondents (71%) had no professional regulatory experience. Of those who did have professional experience, four had had internships in regulatory, three had had the opportunity to interact with a regulatory professional during their experience in another industry role and three were full-time employees who had had experience as or interacted with regulatory professionals before they decided to attend graduate school. Only 32% had regulatory education background, ranging from "exposure at industry meetings" to "regulatory courses" (master's- and doctoral-level courses). See Table 1.

When asked to summarize regulatory in three words, a majority of the respondents focused on either the role itself or characteristics they attributed to a regulatory professional. At first glance, the answers seem to suggest students have an understanding of qualities of a successful regulatory professional. I certainly would be happy if I were described in my evaluations as meticulous, proactive and hardworking. However, a deeper dive into the range of answers revealed inconsistencies among the responses. Some were very specific, such as "submission of marketing authorization applications (NDA, ANDA, BLA, PMA, 510(k))," while others were one word ("Law"). Some of the characteristics-complex and challenging, organized, detail oriented-can be applied to professions ranging from medical affairs to marketing; this would suggest certain students equated a regulatory career to other industry careers. See Table 2.

To see what the students knew about regulatory, they were asked to select phrases, terms and departments with which they were familiar. As seen in Figure 1 and Figure 2, students were very aware of the existence of FDA and its broad regulations (which makes sense considering these areas are covered in most drug development courses in pharmacy school), had a lesser awareness of submissions and submission documents and a low awareness of specific regulatory activities. In a similar fashion, students were very familiar with a few regulatory departments and less aware of others.

Conclusions

As seen in Table 3, students are looking for opportunities to learn more about regulatory. From the results of this small survey, it appears that more widespread and comprehensive outreach by the regulatory profession to students is needed if the goal is to attract the best talent. Many of my regulatory colleagues began their careers either by joining a general developmental program or taking an entry-level position to better understand the healthcare industry. Their goal was to find their niche eventually. If students have a more comprehensive understanding of the regulatory profession, they may be inclined to pursue a specialized training program rather than a general training program to focus on the area about which they are truly passionate.

I knew after my rotation that my interests lay solely in the commercial regulatory aspects of pharmaceuticals, and that desire drove me to seek out a fellowship focused on that area rather than a general regulatory fellowship.

The need for focused developmental programs spans all departments in industry, not just regulatory. My college roommate, who actually persuaded me to study pharmacy but eventually studied biochemical engineering himself, participated in a leadership development program that gave him the opportunity to rotate through process engineering-a role he now supports for oral dosage products.

To develop and retain talent, it falls to industry to identify people with the skills and aptitude for a regulatory role. This process begins by providing students with a comprehensive understanding of the different roles from which they can choose within the industry. For students trying to break into the industry, a good first step is to understand the key differences between various regulatory departments. The findings of this small survey should help convince companies and, specifically, regulatory departments, of the need to conduct additional outreach to relevant educational programs and disciplines to ensure they are connecting with top talent and grooming them to succeed in industry.

About the Author

Richard Lem, PharmD, is completing a two-year Biogen Idec postdoctoral fellowship in regulatory-advertising, labeling and promotion. Lem received his PharmD from the Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey. He can be reached at [email protected].

Cite as: Lem R. "Recruiting for Regulatory--Are We Doing Enough?" Regulatory Focus. February 2014. Regulatory Affairs Professionals Society.