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Career Profiles:

Irene Figari

1. What is a brief description of your job?
video The formal job title is Regulatory Affairs Associate. And as far as a description of the job, it's in regulatory affairs, which is the department's interface between the company and the agency, the Food and Drug Administration. As an associate you learn all aspects of the project for the regulatory piece of it and for product development and under the guidance of a manager. So you're not working independently, but you're learning the job, on-the-job under the wing of a manager.

2. Where did you grow up?
video I was born in San Francisco, California, right up the Peninsula from where we are here. I lived in Nevada, in the United States, Carson City, capital of Nevada for 10 or 12 years and came back to the Bay Area to finish college and work. I've worked and lived here ever since. I live in San Francisco right where I started from.

3. What training and degrees do you hold? What were the specific areas of study?
video The degree that I have is a Bachelor of Arts in biology with a specialty in medical microbiology. I did have, within that major, classes in immunology, virology, chemistry, biochem, and then all the different disciplines of biology.

5. What is the minimum training that is required for your job?
video The minimum training for my job within regulatory affairs would vary depending on the hiring manager, but I would say generally it would be probably 1 to 2 years of background in a science area, very broad based. It could be anything from research, to quality, to manufacturing within industry. Other people would probably prefer 3 to 5 years and there's a very big difference between. . .you can't go to school to learn regulatory affairs.

6. How many years of study are typically needed to acquire the training for your job?
video Years of training for regulatory affairs would be more on the order of the 1 to 2 years of science-- experience in the scientific area in industry.

7. What percentage of an average day is spent using your training?
video For a position as an associate in regulatory affairs, the on-the-job training is critical to acquire the skills to use in a team project development in the regulatory affairs side. The scientific background or training you've had is critical to helping you put those pieces together, to participate in the team environment, to know the science and how it fits in with the regulations and how you can use it to your advantage. The on-the-job training is just the regulatory part and your science background is the complementary part so that together you can help guide the regulatory strategy for a product.

8. What science education, if any, is useful in your field?
video For regulatory affairs I'd say broad based chemistry and biology would be the most useful, biochemistry in particular.

9. What general work skills do you use on a daily basis?
video The work skills for the job are basically the written and verbal communication, ability to participate in a team setting, be well organized and multi-task.

10. Are you working in isolation or with a team of co-workers or subordinates?
video You're always working with a team, whether it's a project team for your particular project or within your department of regulatory affairs. Then you're working and always finding out what other people are doing in the constantly changing regulatory environment. So, it's definitely not independent.

11. What are your working conditions? Dress codes? Environment (Indoor or Outdoor)?
video The environment at this company is terrific! You can wear what you want and we have numerous buildings so you are inside and outside. You just have to pay attention to getting drenched during the winter time, and that's about your only concern. You can dress as you please and it's delightful.

12. What is the biggest challenge you face in your field?
video The biggest challenge in regulatory affairs would be the constantly changing regulatory environment and keeping up with it. The biggest part of the job probably is always helping to design the strategy for your team to keep up with that constantly changing environment.

13. What is the most rewarding experience in your field?
video By far the most rewarding experience in regulatory would be the approval for your product.

14. How did your interest in your field develop?
video I developed an interest in regulatory affairs in that I came from a research based background and research. I think anyone in biotech becomes more and more and more focused and I realized my interests lay more in a broader, bigger picture than a narrow picture on a project. That's what first drew me to look around for other jobs and really attracted me to regulatory. You see the very large picture on a project.

15. What did you want to be in high school?
video What I wanted to be in high school was an interpreter. Translator was my job goal, and obviously that didn't pan out. I love foreign languages so I thought that would be my job choice. My high school language teachers spoke to me and explained to me that it was obviously an area of interest to them. However, it'd be nice to pick a field where I could earn a living and eat! So they strongly recommended against it.

16. Was school easy or hard for you then, and did you like it?
video I can't say it was easy, but definitely on the easy side and I thought that the two things that I didn't like were math and science. And I ended up going into college as a geological engineering major and coming out as a biology major. So, I changed a lot.

17. Are you doing now what you expected to do when you finished school?
video No. I had no concept of this field.

18. What advice do you have for students interested in your field?
video The best advice I'd have for someone interested in regulatory affairs would be try science. Work in industry in some scientific discipline. Look around the companies and see what the different areas do and try to work your way into regulatory affairs. You need the industry experience to get in.

19. Beginning with high school, what science courses do you recommend to prepare for your field?
video To prepare for regulatory affairs any biology or chemistry classes would certainly add, and be advantageous. I think in the chemistry area, biochemistry would certainly be very advantageous.

20. How is the future projection for jobs in this career? Do you forsee an increase in demand in the future?
video I think the future of regulatory affairs is tremendous. As the biotech industry grows and grows, so does the demand for regulatory affairs personnel. So I think it's a tremendously active growth area.

21. Do you use the Internet on a daily basis? If so, how?
video I don't use it on a daily basis but I do occasionally visit websites that are specific to the regulatory field.

22. With regard to your profession, which web sites do you recommend for students interested in your field?
video For people interested in regulatory affairs there are a couple very interesting websites. The Food and Drug Administration has their home page, Department of Health and Human Services is under that. There's an organization called PERI which is Pharmaceutical Education and Research Institute and they have some really interesting links on there. There's another group called PHARMA P-H-A-R-M-A which is Pharmaceutical Manufacturer's Association that again has a lot of things on regulatory affairs issues.

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