Almost 20 years ago, I met Roberto Refeca at a conference and invited him to work in my lab as a summer intern. He did a great job and we have kept in touch ever since.
My advice to him was the same I give to many other students: be aware of the doors that open up along the way as you search for a career path as some of those doors may be quite surprising. Roberto is a great example of someone who did just that. When he was my intern, neither of us knew that a career in Regulatory Affairs would be perfect for him. Here we are all these years later and Roberto has found success and satisfaction as Director of Regulatory Affairs at Clinical Genomics, Inc.
Here is Roberto's story in his own words.
I am Roberto F. Refeca, born in Habana, Cuba, on September 30, 1973, to Olga and Roberto J. Refeca. I am a college graduate with an MBA from the University of Miami, Miami, Florida and a Bachelor’s of Science (Biology, Chemistry) from Maryville University, St. Louis, Missouri. I am a husband to Amy M. Refeca, and father to Sophia C. Refeca and Sammy Refeca. Lastly, Currently I’m working in the field of Regulatory Affairs. I’m the Director, Regulatory Affairs at Clinical Genomics, Inc., a company focused on the early detection of Colorectal Cancer (CRC).
I should explain this now, as it can get very confusing for those that are not familiar with the term Regulatory Affairs. For a company to place a medical device on the market and make it available for sale to the public, they must meet the requirements set forth by the US FDA. The US-FDA regulates products according to the risk/potential risks that they may pose to the user, the risks are largely based on the intended use of the product and the functional attributes and characteristics of the product. The core responsibility for the regulatory professional is to guide companies through this process. Once the product is on the market/distributed, the RA professional also helps companies by interacting with the Regulatory Bodies to maintain the registrations current. Often times the roles for RA professionals within organizations can vary by also including responsibilities for post market surveillance, labeling, and more. I hope that provides some color to my role/profession.
What defines you?
My experiences and my environment define me. I’m an immigrant to the United States, arrived in 1980. A childhood in a lower middle-class environment in St. Louis, Missouri, with friends that took every opportunity to play sports and go fishing. I had many nights of searching our area for lighted spaces where we could play stick ball and basketball, or head to a fishing spot (creeks, lakes, rivers). It was not uncommon for my friends and I to sneak into gymnasiums after hours and on weekends to play basketball during the St. Louis Winters. The fever for sports and fishing started early for me, participating in baseball in middle, high school, and college. The love for the study of Biology came later and was fostered in high school by a couple great mentors Mr. Don McLain and a Mr. Charles Shepperd. Once high school was completed, fast forward through a couple years of undergraduate study (Barry University, Miami, Florida, and then Florissant Valley Community College, St. Louis, Missouri) and then I found myself at Maryville University majoring in Biology with a Minor in Chemistry. To gain additional experience in science, I started volunteering at the Center for the Study of Nervous System Injury (CSNI), Washington University School of Medicine, St. Louis, Missouri, with John W. McDonald MD, Ph.D., during my junior year at Maryville. John’s research interests were focused on mechanisms of oligodendrocyte death, specifically spinal cord injury. While working with Dr. McDonald, it was not uncommon to find ourselves in the lab at 1-3am in the morning on the weekends and during the summer.
In sports, there is god-given talent, and then there is that grind that happens when you work and you know that putting in that extra effort will often yield a positive outcome. I saw this in John, a relentless pursuit with passion for the work that he was doing. It became familiar for me to see this type of behavior that I was so used to being a part of in sports….I was applying it to my love for biology/science, and I saw others with the common approach.
Dr. McDonald invited me the Fall of 1997 to a conference in New Orleans, Louisiana, right around the Halloween time of year. It was here where I had my chanced encounter with a Luz Claudio, Ph.D., if I recall correctly it was during the lunch period when everyone was taking breaks from the conference when we met. As part of our brief conversation Dr. Claudio welcomed me to apply to her summer internship program. I was awarded the opportunity to participate in the program that summer in 1998, in Dr. Luz’s lab at the Environmental Health Sciences Center, Mt. Sinai School of Medicine, New York, New York. My work included trying to establish a cell culture model of the blood brain barrier using astrocytes and HUVEC (Human umbilical vein endothelial cells).
After that summer I ended up in Miami, Florida. After working as a baseball instructor at Red Berry’s baseball academy, I then started my professional working career (after being a college graduate) working at the Diabetes Research Institute (DRI), University of Miami School of Medicine. The work was amazing, I was a part of the Human Islet Transplant team. In short, the program leaders were Camillo Ricordi, MD, Norma Kenyon, Ph.D., and Rodolfo Alejandro, MD. Our focus was finding a cure for Type I diabetes via the transplantation of islets, the insulin producing cells within the pancreas. My job was to isolate islets for transplant and for research from cadaver pancreas, it was not uncommon for the harvesting procedure to take 4-12 hours in the lab. As part of the DRI program I was also able to experience technology related to the processing and harvesting whole bone marrow for transplant from cadaver bone marrow, and living donor iliac crest aspirates. The science that was happening at the DRI was second to none, and I enjoyed every part of it.
After working in science/the lab for a number of years at the DRI, I had thoughts of graduate school/focus on science. It was always my dream to drive research to a clinical benefit in people. I also started to yearn for a different challenge within science that would include more interaction in non-lab settings, getting closer to the interphase between research and clinical practice. That lead me to my decision to pursue an MBA at the University of Miami, Miami, Florida. After I finished the MBA program, I then took a job with Cordis Neurovascular in Miami, Florida which was a division of Johnson & Johnson. It made more sense than what I knew at the time.
How did you decide on this career path?
This is a great question, I have not met a person yet in my career that by design ended up in the field of Regulatory Affairs (I’m sure that they are out there), most persons including myself end up in Regulatory Affairs in a “sideways” type of manner in that there are not many college programs that offer RA degrees. I have had colleagues with undergraduate training in: science, engineering, communications, and graduate degrees such as MBA, MSc., Ph.D., JD.
What you like, don't like?
What I love about my current role and the field of Regulatory Affairs. It is very broad: I’m at the forefront of a technology/science in bringing new things to market and it also requires me to communicate effectively with a broad group of persons/groups within my organization. Regulatory Affairs also requires me to communicate effectively with persons outside of my organization which can be customers to the business and regulators globally. It is common for me to have routine conversations with: sales, marketing, operations/manufacturing, research & development, legal, and finance/accounting.
In my various roles I have interacted with a very diverse group of professionals in all of the global markets, the professional relationships that I still keep today are priceless. And because my roles have been global in nature, I’ve had the chance to interact with regulators from around the world including: Canada, EU-Notified Bodies, Mexico, Costa Rica, Australia, and of course our US-FDA. In today’s world, business is global and regulatory is a key partner to any company’s global success whether it be the introduction of new products or maintaining products in existing markets.
What do you wish you had known before you embarked in your career?
In hind sight, I sometimes wonder what it would have been like to have started earlier in the field of Regulatory Affairs….but that is only a brief thought, I enjoyed my time in research too much: Washington University School of Medicine (Study of Nervous System Injury); Mount Sinai School of Medicine, New York (Environmental Health Sciences Center); and the University of Miami, School of Medicine (Diabetes Research Institute), Miami, Florida. The places, people, and experiences, I’m thankful for each.
What would you advise others thinking of similar career paths?
With regards to the field of Regulatory Affairs, my belief is that it is helpful to bring a skill set to the profession (science, technology, engineering, math) and that one of the most important attributes is to have good interpersonal skills including the ability to communicate effectively (verbally and in writing).
What have been some of your biggest obstacles and how have you overcome them?
Myself. We often get in our own way by over analyzing things or lacking self confidence. The way to overcome is to take chances, and if things don’t workout you re-direct. I believe this is a key to life and to success. Don’t be afraid to make a mistake, acknowledge it, own it and move on. If you miss “acknowledging” it, I believe this can be a detriment to leadership and slow your development.
Don’t pass up opportunities, take chances!
How has your background, gender, race, or any other aspects of yourself been an asset?
The fire inside of me comes from my background, gender, race. Being an immigrant to the United States, which I believe is truly a place of opportunity whereby you can own your trajectory…what was instilled in me since being a very young boy is that I was different and that I had to work, work, work to have access to the things I wanted. In sports, in school, in my work, I was raised to not be outworked. I have learned in sports and in my profession that hard work does not always immediately yield what you expect, but if you keep at it…the model stands up and the results are there.
This approach is common in sports and has a common thread in life with work and relationships.
Growing up in St. Louis, Missouri my parents and family, we routinely spoke Spanish in stores, around town which was not as common in the early 1980’s compared to today. We would get funny looks at times. This language skill that I did not think much of in my childhood also had a significant impact on my professional development when I entered the field of Regulatory Affairs. English is the global language for business, however, when I interacted with my colleagues in Latin America being able to read and speak, and write Spanish was a huge asset. The best part was that I routinely take the opportunity to work on my Spanish while my international colleagues use the opportunity to work on their English.
Overall, I’ve had the kinds of experiences that any ethnic minority has in the United States. I can say with certainty that the eyes and ears of your colleagues and bosses are blinded to your differences when you bring value and success to the work.
I am very thankful for the persons that I have shared my career with, very thankful and humbled by my experiences.
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Dr. Luz Claudio is an environmental health scientist, mother and consultant, originally from Puerto Rico. She is a tenured professor of environmental medicine and public health. Luz recently published her first book: How to Write and Publish a Scientific Paper: The Step-by-Step Guide. Dr. Claudio has internship programs and resources for young scientists. Opinions expressed in this blog are solely her own and may not reflect her employer's views.