Regulatory Open Forum

Hello RAPS community,

My Background:

My name is Arsh and I am currently a senior undergraduate student and UC Berkeley. I am interested in pursuing a career in regulatory affairs including but not limited to assisting in clinical trials, coordinating with PI, sponsors, and regulatory bodies, maintaining and submitting all the regulatory documents, quality control, etc. I have two years of experience in conducting pre-clinical studies (lab work with patient samples)  for COVID and developing a point-of-care test for COVID. This experience made me curious about clinical study design, analysis, and more in clinical trials and the regulatory side of clinical research.

Main Question:

I am also interested in getting a master's in clinical research to get in-depth training on these concepts and advance my knowledge on how to design/conduct/implement a study, analyze data, and work with various departments on marketing, budgeting, making a master protocol, learn about current ethical and regulatory standards. My experience is mostly in wet lab training (R&D) and I am not exposed to helping in conducting research with human subjects yet.
Do you think I should pursue a master's to solidify my knowledge in these subjects and start as an entry-level regulatory specialist or get work experience first in regulatory affairs and then pursue a higher degree? In getting work experience first,  for someone who has no experience in regulatory affairs how likely it is to get an internship or job in this field? 

Hi Arsh.

I can only speak for myself on this and it is truly just an opinion.  However, I would strongly suggest trying to get some sort of experience before going on for your graduate level degree.  Reason is simple - cost, time, and prospects for work.  Let me explain a little more.

First, the obvious issue of costs.  Without a job in the field you are looking to break into you are likely to have to pay the costs of the program entirely on your own.  Yes, it is possible and depending on your situation even probable that you would get some sort of assistance from the school to pay for the costs but anything you do pay is going to come directly out of your own funds.  With a job in the field, many companies today will help (or even pay entirely for - yes I had this beautiful benefit when I got my Masters!!!) defer the costs either through a tuition reimbursement program or even "scholarship" opportunities that they might provide.  Also, it is far easier to come up with a final project (should there be a requirement for the program you ultimately join) if you are already in the basic field and business rather than trying to figure out a project where you have no previous exposure.

Next is the time element.  While working in the field might cause some difficulties in finding the time to study and do whatever work is required for each of your classes, it is often more difficult to try to get the work done while you are actively looking for a job in the field.  This is because of the unpredictability of interview schedules as well as your own need to continue to earn some sort of paycheck while in school to pay for other bills.

Finally, and maybe most importantly, the prospects for work after completing the degree.  In my experience as a hiring manager, students often forget that the pay scale for a job is not based entirely on the candidate but equally (and sometimes moreso) based on the job description of what that candidate will be responsible for in the day-to-day operation.  Someone coming out of school with a Masters and no real-world experience is far more likely to have difficulty breaking into the business than someone coming out with a bachelors.  Also, many companies are willing to take on interns especially if they are still in school in their undergraduate years because of the tax incentives that exist.  These same incentives may or may not carry over to the folks going through their graduate degrees especially if a graduate degree is not a requirement for the position to begin with.  Also, when hiring, many students entering the field seem to have this idea that because they have a graduate degree they are somehow able to command a higher salary but this may not be the case - see my point earlier about how salaries are typically determined.  Many times hiring managers will look at the fact that you have a graduate degree and zero experience in the area and they will simply pass over your application.

All of this is a long way of saying try to get some experience before starting your graduate studies.  Who knows?  You might find out that you were interested in clinical but with the experience you determine your real passion is in regulatory policy or something completely different!

Hello RAPS community,

My Background:

My name is Arsh and I am currently a senior undergraduate student and UC Berkeley. I am interested in pursuing a career in regulatory affairs including but not limited to assisting in clinical trials, coordinating with PI, sponsors, and regulatory bodies, maintaining and submitting all the regulatory documents, quality control, etc. I have two years of experience in conducting pre-clinical studies (lab work with patient samples)  for COVID and developing a point-of-care test for COVID. This experience made me curious about clinical study design, analysis, and more in clinical trials and the regulatory side of clinical research.

Main Question:

I am also interested in getting a master's in clinical research to get in-depth training on these concepts and advance my knowledge on how to design/conduct/implement a study, analyze data, and work with various departments on marketing, budgeting, making a master protocol, learn about current ethical and regulatory standards. My experience is mostly in wet lab training (R&D) and I am not exposed to helping in conducting research with human subjects yet.
Do you think I should pursue a master's to solidify my knowledge in these subjects and start as an entry-level regulatory specialist or get work experience first in regulatory affairs and then pursue a higher degree? In getting work experience first,  for someone who has no experience in regulatory affairs how likely it is to get an internship or job in this field?