Scott Harris is a native San Diegan and San Diego State University alum who started his career in the lab and progressed to a senior role in regulatory affairs. We had an opportunity to discuss Scott's career path with him during a recent interview:
Q: Where do you currently work?
A: I most recently (July 2010) worked for
Corthera, a start-up
biopharmaceutical company based out of
San Mateo, California. Corthera is focused on
developing therapies for the acute care setting,
with the initial target of acute heart failure
The company was acquired by
Novartis Pharmaceutical Corporation in
February, 2010.
Q: What was your role at Corthera?
A: I was their Head of Regulatory Affairs &
Quality Assurance. I was responsible for the
worldwide regulatory affairs and quality assurance
for the company related to the development
of the biologic Relaxin. In my
role, l ensured the company was in compliance
with regulations and laws and guided
them through the drug development and
approval process with the FDA.
Q: What is a typical day like for you on
the job?
A: Everyday is different. I provide guidance
on ongoing clinical trials and do risk mitigation.
I ensure the company is in compliance
with all applicable laws and regulations governing
drug development, including clinical
trials and drug manufacturing. I work with a
broad cross section of functional groups so
each day presents new and different challenges.
Q: What skills are necessary to be successful in your job?
A: You must have a very good understanding of the drug development process and have the ability to work with a variety of functional areas in a company. Having very strong interpersonal skills and experience working with multiple areas of a biotech company is important.
Since many of the laws and regulations are very vague, a person must be able to understand the true intent. Therefore, the person must be detail-oriented and have good analytical skills. Having a science background is also important so you can easily understand technical information.
Individuals that typically go into regulatory affairs have worked in clinical trials or manufacturing and have worked in multiple areas of a company.
Q: What do you like most about what you do?
A: I like the variety of my job function. I encounter different problems and issues everyday. Many people think that being in regulatory affairs is all about "pushing paper", which is not necessarily the case since there is a lot of interaction involved. I also like that l can be involved with science without being in a lab.
Q: How did you end up working at Corthera?
A: They were a consulting client of mine for two and half years. I acted as Head of Regulatory Affairs and Quality Assurance for them when l was a consultant and then decided to join them full time in January 2009.
Q: Where have you worked before?
A: I was a Research Associate at Biosite Incorporated when l was completing my Bachelors in Biochemistry and Cell Biology from UCSD. After l graduated l continued along a similar path and served as a Research Associate at Angstrom Pharmaceuticals based in San Diego. After being at Angstrom for a year, l realized that l didn't want to be in the lab anymore and decided l would go to law school. I got accepted into law school but soon after got approached by a former manager to join a new pharmaceutical company he was starting in San Diego called Attenuon. It was an opportunity to join a thriving start-up company l just couldn't pass up so l decided not to go to law school and joined Attenuon instead. I initially joined as an Associate Scientist. I then decided to enroll in the SDSU Master's in Regulatory Affairs program and was able to move into a management role at Attenuon heading regulatory affairs and quality assurance. After being with the company for a little over four years, l left for a Senior Manager, Regulatory Affairs position at BioMarin Pharmaceuticals in Novato, CA and later went on to build a consulting practice.
Q: Why did you choose to go into Regulatory Affairs?
A: I wanted to stay involved in science, but move out of the lab. I was also very interested in law. A career in regulatory affairs allows you to stay involved in all of the scientific aspects of drug development, but not be in the lab doing research.
Q: What is your educational background?
A: I have a M.S. in Regulatory Affairs from San Diego State University. I have also become a lecturer and course facilitator for the program. I have a B.S. in Biochemistry and Cell Biology from UCSD.
Q: How did your education play a role in where you are now?
A: The SDSU M.S. in Regulatory Affairs solidified my move to go into regulatory affairs. Since l was taking the program while l was working, I was able to apply what l was learning in the program in real time on the job.
Q: What are your near-term and long-term career goals?
A: I would like to continue to do consulting in the near-term and then ultimately join a start-up company again. I enjoy working in a start-up environment because you get more opportunities to learn and are provided more responsibility.
Q: What advice would you give to students and professionals currently in the life sciences industry considering a career in Regulatory Affairs?
A: I would strongly encourage students interested in regulatory affairs to get some formal training in order to get more exposure and understanding of the field. I would also encourage them to talk to different people currently working in the drug development area. There are a lot of different job functions in drug development, so speaking to people to gain an understanding of their role and typical job duties is important.
Q: Is there anything else you would like to mention?
A: Being level headed and not reactionary is important. If you want a role in regulatory affairs you need to be analytical and be able to look at the whole picture. By working in a small company you will get a lot more exposure.
Field: Regulatory Affairs
Job: Regulatory Affairs & Quality
Assurance Consultant
Education:
M.S. Regulatory Affairs from
SDSU; B.S. Biochemistry & Cell Biology
from UCSD
Certifications:
Regulatory Affairs Certification
(Blue=B.S. degree, Orange =M.S degree)
