Ángel Casanova-Torres earned his bachelor’s degree in Microbiology at the University of Puerto Rico-Humacao where he was a McNair Scholar, an Honors Scholar, and an undergraduate research fellow conducting independent research under the U.S. Environmental Protection Agency’s Greater Research Opportunities Fellowship Program. He came to UW–Madison to pursue graduate training in the Microbiology Doctoral Training Program and was part of the Science and Medicine Graduate Research Scholars community as well as the Molecular Biosciences Training Grant program. He completed his dissertation in the Goodrich-Blair laboratory and earned a PhD in Microbiology in 2016. After earning his PhD, he worked as a postdoctoral research associate in the Medical Entomology Laboratory at UW-Madison. Following his postdoctoral appointment, he worked at NorthStar Medical Radioisotopes as a Quality Assurance Microbiologist. Now, as a Senior Regulatory Affairs Specialist at Exact Sciences in Madison, Ángel is a liaison on regulatory affairs for his colleagues, providing strategic and technical advice for the development and commercialization of healthcare products.
Tell us about your path from graduate school to your current position.
During my third year of graduate school, I started exploring career options outside of academia by comparing my skill set and core values to those associated with different career paths. Thanks to this I learned about Regulatory Affairs (RA) and immediately felt that it was the right fit for me. RA professionals ensure that companies in various industries (e.g., food, biotechnology, pharmaceutical, medical device) follow regulations and industry standards for producing safe products. They act as a liaison between the business and regulatory agencies. Working in RA is essentially working at the intersection between science, business, and law. The skill set required in RA is similar to the skill set you develop during graduate studies – for example, oral and written communication skills, organization, time and project management skills, and the ability to work as a member of a team. In addition, RA professionals must have a passion and aptitude for highly detailed work. The core values that drove me to pursue graduate studies are some of the core values that RA professionals embrace such as being able to do meaningful and challenging work, continuous learning, objectivity, and accountability. Therefore, a career in RA allows me to do work that aligns with my skill set as well as my core values.
While in graduate school, I took online courses in several areas of RA, I read all I could find about the RA profession, and I had informational interviews with RA professionals. I learned that a direct transition from academic research to a career in RA can be challenging. Accordingly, after a short postdoctoral appointment, I leveraged my training in microbiology and what I had learned about RA and I joined a pharmaceutical company to work as a Quality Assurance (QA) Microbiologist. QA professionals ensure that products meet company standards by developing and implementing inspection activities and detecting and solving problems. In this role, I had the opportunity to learn and understand the business processes and regulations required to ensure products are manufactured to meet industry standards. After two years working in QA, I transitioned to a role in RA at a medical device company where I help bring healthcare products to market and ensure that on-market products continue to comply with regulations and industry standards.
What do you do in your current role?
I create regulatory strategies to align regulatory requirements and activities to business needs with the end goal of bringing healthcare products to market. I participate in cross-functional teams and provide regulatory advice at all stages of the healthcare product life cycle, from development to post-market activities. I review procedures, protocols, technical documents, reports, and product labeling to ensure alignment with regulatory requirements. In addition, I prepare regulatory submissions to obtain appropriate commercial distribution authorizations from regulatory agencies.
What do you like about this job? What is challenging?
One of the most exciting and rewarding aspects of a career in RA is that you get to be at the forefront of scientific development and play a key role in the development and availability of healthcare products that help people. The knowledge and understanding necessary to do this extend beyond regulatory requirements, which is a challenge in and of itself with regulations constantly evolving. This requires a commitment to ongoing training and career development which, albeit challenging, can be intellectually stimulating.
What skills from graduate school are the most useful to you in this job?
Critical thinking tends to become intuitive when you are trained as a scientist and this has been the most useful skill to me in my role in RA. Critical thinking is essentially what a regulatory professional does on a day-to-day basis: recognize problems, identify solutions, interpret data, evaluate evidence, and draw warranted conclusions and generalizations. The ability to question, interpret, and communicate is key to successfully perform the tasks associated with a role in RA.
What kinds of things did you do as a student that you believe made you competitive as a job candidate throughout your career?
While in graduate school I invested as much time as possible in career development activities to obtain a knowledge base in RA. I took several online courses provided by the Regulatory Affairs Professionals Society (RAPS), including introductory courses to Regulatory Affairs in the U.S., Canada, and the E.U., Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice. In addition, since regulatory decisions have an impact on business outcomes, I took elective business courses as a graduate student to gain a basic understanding of business principles.
What advice do you have for current graduate students interested in this type of career?
Training as a scientist helps develop some of the most critical skills required to be successful in RA including critical thinking, writing, and communication skills. My advice to students interested in this type of career is to invest time in learning about the regulatory environment for the industry they are interested in and to seek opportunities to work in industry as early as possible. I suggest participating in professional societies such as the American Society for Quality (ASQ) and the Regulatory Affairs Professionals Society (RAPS) which offer a variety of education, training, and career resources. Also, I would recommend doing an internship or co-op while in graduate school to gain hands-on industry experience; there are some internship opportunities in RA that can give you a firsthand look at what is involved in RA.