A Regulatory Internship: Is It Worth It?

Budding regulatory professionals may want to consider an internship during their university years to enhance their knowledge and improve their job prospects later on. Interestingly, few reports have been published on the subject of regulatory internships, so this personal account may help guide the undecided by providing insights on merits and downsides.

In August 2013, I began a four-week internship in the consulting department of a leading contract research organization (CRO) and consulting firm in London. Still a pharmacy student, I was eager to gain hands-on industry experience. As one of the first to undertake an internship at this company, I was somewhat apprehensive as to what to expect.

However, my qualms were quickly assuaged. Upon my arrival, I was met by one of the department managers who gave me a brief, informative talk on the consulting department's responsibilities and how they align with the rest of the organization. I was then introduced to the consulting staff comprising professionals from diverse backgrounds including industry, consulting and academia.

Internship Tasks

One of my first tasks was to understand what constitutes a regulatory dossier and the Marketing Authorisation (MA) Application process. I sought understanding by using various online resources including the European Medicines Agency (EMA) website. I came to learn that a dossier consists of five independent modules (administrative information, Common Technical Document (CTD) summaries, quality, preclinical study reports and clinical study reports). I now understand that these modules provide extensive information on a drug and its clinical trial data, and that these modules are submitted for review by the relevant regulatory authority to determine whether the drug is suitable for market release.

Subsequently, I was set to work on IDRAC, a regulatory affairs database, which required me to pool information on regulatory standards for dossier submission in 30 different countries where the company has projects. I found this information on the relevant regulatory authorities' website for each country. I entered the pooled information into a separate general CTD template for each country, which had already been produced by a colleague. This was an ongoing task designed to reduce the overall workload for my co-workers.

The task proved particularly challenging, as not all countries follow the generic CTD format. The wide variations in requirements for the compilation of dossiers built up my experience on the submission procedures of some countries. However, problems began to arise when I encountered limitations on the information available on regulatory sites for particular countries. These were usually in emerging markets, where little could be found about their dossier submission processes.

Also, aided by a colleague, I was tasked with researching and identifying the specific drugs approved for second-line treatment of major depressive disorder (MDD) in the UK. These data were to be relayed to an overseas pharmaceutical organization as market research on their competitors. We found Cymbalta, Prozac, Zyprexa and Risperdal to be approved therapies.

Moreover, I was given the chance to use other skills when given a Microsoft Excel spread sheet dealing with the rates at which consultants can charge clients for their services depending on their level of experience. I used this information to calculate the percentage of the total budget used and hence evaluate their cost efficiency per project.

Continual Professional Development

In addition, I observed that work requirements at the company call for continuous professional development and staying up-to-date with current regulatory events. This became evident when I was instructed to carry out research on the changes being made to the EMA dossier submission process. Beginning in March 2014, all electronic common technical documents (eCTDs) are to be submitted via an online gateway; CD or DVD submissions will no longer be accepted. The timeline for this task was tight as the company emphasizes the importance of all regulatory staff keeping up to date with current regulatory processes.

To increase my exposure to the regulatory sector, I was asked to compile a weekly report of current regulatory news that could prove useful to members of the consulting department, depending on the particular projects and clients with which they were dealing. This report included noteworthy events, new legislation, MA approvals and newly launched medications.

Summary

In all, this internship has been an eye opener, far exceeding my previous experiences with summer internships, which entailed tedious scanning and photocopying. I received a good deal of useful advice and career guidance from the consultants I worked with. Also, I was introduced to LinkedIn, the professional network, which will allow me to keep in contact with my internship colleagues after leaving the CRO.

Exposure to such a professional environment and working with such knowledgeable and friendly people has motivated me to pursue this career avenue soon after graduation in 2015. Furthermore, this experience will help strengthen my future job applications in industry. The types of tasks I was involved in, and dealing with multiple deadlines simultaneously, underscored the importance of meeting deadlines and improved my organizational skills.

I urge any student or professional interested in regulatory consulting to participate in a similar internship. It is highly valuable experience and you will most definitely have a broader perspective of the industry when you finish.