Career Profiles:
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Irene Figari
1. What is a brief description of your job?
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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.
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2. Where did you grow up?
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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.
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3. What training and degrees do you hold? What were the specific
areas of study?
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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.
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5. What is the minimum training that is required for your job?
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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.
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6. How many years of study are typically needed to acquire the
training for your job?
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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.
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7. What percentage of an average day is spent using your
training?
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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.
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8. What science education, if any, is useful in your field?
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For regulatory affairs I'd say broad based chemistry and biology would
be the most useful, biochemistry in particular.
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9. What general work skills do you use on a daily basis?
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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.
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10. Are you working in isolation or with a team of co-workers or
subordinates?
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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.
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11. What are your working conditions? Dress codes? Environment
(Indoor or Outdoor)?
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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.
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12. What is the biggest challenge you face in your field?
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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.
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13. What is the most rewarding experience in your field?
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By far the most rewarding experience in regulatory would be the
approval for your product.
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14. How did your interest in your field develop?
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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.
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15. What did you want to be in high school?
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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.
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16. Was school easy or hard for you then, and did you like it?
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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.
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17. Are you doing now what you expected to do when you finished
school?
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No. I had no concept of this field.
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18. What advice do you have for students interested in your field?
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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.
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19. Beginning with high school, what science courses do you
recommend to prepare for your field?
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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.
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20. How is the future projection for jobs in this career? Do you
forsee an increase in demand in the future?
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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.
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21. Do you use the Internet on a daily basis? If so, how?
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I don't use it on a daily basis but I do occasionally visit websites
that are specific to the regulatory field.
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22. With regard to your profession, which web sites do you
recommend for students interested in your field?
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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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