Internships -- One Pathway to a Regulatory Career

The regulatory profession continues to grow and evolve into greater responsibilities, creating a need for new workers who are better prepared to enter the profession. Individuals continue to be interested in regulatory either as a first career or as a career transition. However, today we see that most entry-level regulatory positions require some regulatory experience because, increasingly, the work is more technical, managers have limited time to train inexperienced workers and companies want new hires to be productive immediately.

While those wanting to enter the profession often augment their educational background and previous related experience with regulatory seminars, classes or even certificate or degree programs, the lack of regulatory work experience still is a barrier for many and can significantly delay obtaining a job.

Internships can provide valuable experience as well as a path to a regulatory career.

Many life science companies currently fill short-term positions by hiring temporary or contract workers. Some have an established internship program for high school or university students during the summer months, but these types of internships do not always include working professionals or a regulatory affairs position.

Several years ago the San Diego Regulatory Affairs Network (SDRAN) initiated a program to encourage more local companies to provide regulatory internships as a vehicle to bridge the experience gap. This article describes the successes and issues encountered in that effort. It is hoped that this article and this program will encourage more regulatory managers to offer internships and prompt other local regulatory groups and RAPS chapters to assist in that effort.

Closing the Experience Gap with Training, Certification, Mentoring and Internship

Individuals transitioning to a regulatory affairs career can enhance their qualifications and open job possibilities in several ways. Three tools (training, certification and mentoring) are commonly used to increase career preparation and this article recommends making a fourth (internship) more readily available.

Training: One approach is taking university classes to obtain a certificate or master's degree in regulatory. A number of universities, many online, offer such programs. A large number of organizations, including RAPS, offer training seminars and webinars on defined topics to fill specific knowledge gaps.

[media:1533:embed:left]

Certification: Another opportunity for developing a broad regulatory knowledge base is to study for the RAPS exam for Regulatory Affairs Certification (RAC). Employers now look for the RAC credential when filling many entry-level positions. A number of regulatory organizations offer study groups on the key subject areas covered by the RAC exam.

Mentoring: Several regulatory organizations have programs through which experienced mentors provide career advice to junior professionals wishing to transition to or advance in a regulatory career. The advice provided is usually personalized to the junior professional and can include identification of qualification gaps and suggestions for résumé revisions, networking opportunities and further training.

Internships: Internships can offer short-term work experience such as completing a project or activities typical of an entry-level regulatory position; however, the availability of regulatory internships is limited.

Facilitating More Internships

The SDRAN internship program involves partnering with local life sciences companies to provide interns with supervised regulatory work experience, usually over a period of three to six months. This provides a meaningful work experience for the intern and at the same time contributes to the goals of the company.

SDRAN formed an Internship Committee to promote the value of internships to local industries and to oversee the program. The committee members continually network with local hiring managers, describe the program in local trade association newsletters and on the SDRAN website and discuss it at the group's educational programs. For example, at an educational program an intern and supervisor shared their experience. The committee also encourages employers to consider providing an internship in lieu of hiring a temporary or contract worker.

A successful internship begins with a clear position description from the company, identifying specific tasks and learning opportunities. The intern's manager must plan sufficient time to instruct, mentor and provide feedback and the company should ensure the assignment is meaningful and provide adequate work space and equipment. Company policy and applicable laws determine compensation for the intern.

SDRAN recruits intern candidates by posting the company's position description on the SDRAN website (www.sdran.org), sending direct mail to its membership, posting on social media (LinkedIn), contacting local universities about the opening and mailing directly to potential candidates who have previously indicated an interest. The application process requires the candidate's résumé, a letter of recommendation and a statement of what the candidate hopes to accomplish during the internship. The SDRAN committee conducts a brief review of each candidate prior to forwarding their applications to the hiring manager. After reviewing the applicants' documents, participating companies choose candidates to interview and then select the most suitable candidate for the internship.

At the end of the internship period, the SDRAN committee requests that both the supervisor and intern provide a written evaluation of the experience. Several interns have been offered full-time positions at the end of their internship, leading directly to a regulatory career for some individuals.

Internship Program Lessons Learned  

Employers: SDRAN's experience with employer issues includes concerns regarding the time commitment required vs. benefits to be gained. The committee found that supervisors who travel frequently cannot usually provide the desired amount of guidance. In one case, an employer sought an individual with more experience than is typical of an entry-level internship. Some hiring managers were not familiar with internship compensation requirements so SDRAN provided information about what others were doing or they were referred to their human resources department for additional guidance. Because many departments did not have a budget for an internship, the committee provided information about the program to support a future requisition.

Internship candidates: The committee initiated an application screening process to ensure that only applications from candidates who were ready to be interviewed were forwarded to the hiring manager. The committee now pre-screens candidates' applications for the ability to work in the US and to commit the necessary time. This process was established after the committee found some candidates were ineligible to work in the US and some had full-time jobs that they were unwilling to quit for a temporary internship. The committee also requires candidates to submit a complete application by the deadline.

Following are examples of successful and unsuccessful internships:

• Successful: An individual with experience in drug clinical research was selected from seven candidates for a regulatory internship at a medical device company. The manager was an excellent teacher and mentor. Following this successful internship the intern was hired by the company as a regulatory affairs analyst.
• Unsuccessful: At another company, the manager traveled frequently and was out of the office for extended periods. The intern was frustrated by the lack of communication, and neither she nor the manager was completely satisfied with the internship.

Conclusion

Internships can provide a bridge to a regulatory career for individuals at the outset of their careers as well as experienced professionals seeking a career transition. The SDRAN program demonstrates the effectiveness of a regulatory organization's promotion of internships to companies to expand the number of new regulatory professionals. Managers and interns have reported that completed internships provided valuable experience to the interns while helping the managers meet corporate goals. Most of the SDRAN-sponsored internships have been successful to date, and several interns have made a career transition into regulatory. While the SDRAN program has increased the number of internships, currently there are more candidates than opportunities available. SDRAN continues to publicize the program and actively contacts local regulatory departments to encourage internships.