Masters Degree Completed in Quality Assurance and Regulatory Affairs

    12/08/2017

     

    This week I completed my last and final class on the Temple University Quality Assurance and Regulatory Affairs degree program. I am now set to graduate with the masters degree, after my final grades come in. It has been an honor and a pleasure to study with the best and brightest industry professionals in the America's oldest Regulatory Affairs degree program. When I first set out to study for the Drug Development certificate three years ago I really wanted to explore a new area out of curiosity, not really knowing what to expect from industry and wanting to venture outside of my comfort zone in academia. My hardcore academic friends remain baffled by such a decision to go back to school and study anything at all, after having done a neurobiology PhD and a decade of postdocking. Three years later, I have acquired a broad spectrum of knowledge about the pharmaceutical development processes and gotten some insights into planning regulatory strategies with the FDA. I have also held some interesting study group interactions with industry classmates and met some great teachers along the way.

    No one grows up saying "I want to be a regulatory affairs professional" or "I want to be a Quality Assurance specialist" and as an academic scientist, complying to SOPs is the last thing on your mind while you try to make discoveries. However, studying these classes has opened up my eyes to entirely new worlds of career possibilities and focused my attention on some of the biggest issues the biotech industry and world governments face today. Furthermore, during the time I attended classes, I have seen in real-time the impact of food and drug regulations on the industry. Sometimes there are devastating consequences when organizations either ignore or defraud the FDA and mishandled QA inspections - just look at Theranos and Dr Reddy's. Sometimes there are exciting prospects when the FDA Advisory Committee is presented with controversial data for life-saving but minimally tested biologic therapeutics (Sarepta's Exondys 51 drug). The most striking lesson I learnt was in Food and Drug Law class: that the CEO is ultimately responsible for the company's failings (Park Doctrine, Acme food scandal). Even if employees failed to keep rodents out of the food storage facility, that deficiency was ultimately because of mismanagement from the chairman, who was subsequently fired because of it! A powerful lesson!

    While I have not managed to find a direct entry point into a career in regulatory affairs or quality assurance I hope my degree will provide leverage for future interactions with this discipline and maybe someday land me in the good books of FDA reviewers. Who knows, I might even be able to work with them in future!