Tooling Up: The Regulatory Affairs Career Track - From Science Careers

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http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2009_09_18/caredit.a0900112

Tooling Up: The Regulatory Affairs Career Track

By David G. Jensen

September 18, 2009

"Anyone who has an interest in the regulatory field must have a very
pronounced love of detail. ... While the regulatory elements of a job
like this can be learned, if you can't manage tiny nuances of data in
a multigigabyte document, you're in trouble." --Shannon Strom

Regulatory affairs specialists work at the interface between business
and government regulations, shepherding medical products from
inception to market. It's a career track that can move you quickly
from newbie to manager, reward you with weighty responsibility for
important projects, and pay you more than what you would have earned
if you had stayed at the bench.

However, a job in regulatory affairs (RA) is also one of the most
difficult transitions for a postdoc or graduate student. Not only is
it difficult to land an entry-level RA job, it's an incredibly
demanding post. The work is very detail-focused, as it involves
writing and reviewing documents that are thousands of pages long. It
requires an understanding of science and business, as well as
government language and procedures. The pressure can be intense--but
it's important work, and for scientists with the right mindset it can
be an excellent career.

Jobs on this career track are found in all sorts of companies: biotech
and pharmaceuticals, medical devices, diagnostics, cosmetics, and even
nutritional products. The best way to learn more about RA--after
reading this column--is to set up informational interviews with people
who work in the field. Also read the extensive feature on RA careers
that Science Careers published back in 2003. This month's column will
start you off with a success story.
A desire to make a difference in patients' lives
Tooling Up, Dave Jensen

(Kelly Krause, AAAS)

Shannon Strom is a senior regulatory scientist and associate director
of regulatory operations at CATO Research in Durham, North Carolina.
She did her Ph.D. in pharmacology at the University of North Carolina
(UNC), Chapel Hill. "One of my favorite experiences in my lab had been
a collaboration with an M.D./Ph.D. who had a direct connection to
patients in my area of interest," Shannon told me. "It really got me
interested in helping people more directly, as opposed to simply doing
another in vitro assay."

So as she neared the end of her Ph.D. in 2005, she focused her
attention on opportunities and postdoc positions that could lead her
to a clinical or drug-development position down the line.

"I took classes intended for those in drug development at UNC and
participated in local meetings of both SoCRA [the Society of Clinical
Research Associates] and RAPS [ Regulatory Affairs Professionals
Society], both of which have active chapters here," Shannon says. She
also sought a Regulatory Affairs Certificate (RAC), which is normally
pursued by RA professionals with at least a few years of experience in
industry.

She initially felt that clinical trials management would be the best
area for her to work in. She wasn't yet RAC-certified when she began
her job search, but her experience working with patients during her
Ph.D., and her networking in both clinical trials and regulatory
circles, gave her an edge that made her very competitive for jobs.

After researching the field locally, she found the CATO Research
Fellows Program. CATO doesn't do drug development; rather, the company
provides services to the drug development teams in other companies.
Those services include clinical trials management and U.S. Food and
Drug Administration (FDA) new drug submissions and marketing
applications.

CATO fellows train in an intense, 12-month program. Shannon was
assigned the job of medical writer, where she helped assemble
regulatory submissions. A full-time job isn't guaranteed at the end of
CATO's fellowship; like many industry postdocs, CATO fellows are
offered a job only if they've performed well and met certain criteria.
Shannon was pleased when, during her 12-month review, she was asked to
stay on to fill an open position as a regulatory scientist.
The life and times of an RA scientist

From day one, Shannon loved her job in RA. "Regulatory at our company
is split into two categories: Regulatory Strategy and Regulatory
Operations," Shannon says. "I have client interactions on the strategy
side, and both client and FDA interactions on the operations side, and
manage personnel in both areas."

Shannon's strategy work has included meeting with a client company to
discuss the launch of an investigational new drug (IND) application.
"This client has just begun the process of what will be a long road,
and they need our advice on how to get their compound into the
clinic," she told me.

On the operations side, her work is more about "the nuts and bolts of
the process," she says. On the day I spoke with her, she had just met
with a company about a marketing application for one of its products--
the end of the line for a compound making its way through the
regulatory process. She's been involved in all aspects of the
application, which now consists of hundreds of thousands of pages. (In
the old days, before electronic submissions, a marketing application
would require an entire moving truck!)

The art is in writing the summaries that go into each section of these
applications. Each is less than 100 pages long and must be evidence-
based and very convincing. Shannon's company was instrumental in three
of the 21 new drug applications the FDA approved last year.

Scientists working in RA cross the border between strategy and
operations in the important area of product labeling--that little
folded piece of technical fine print that is in every prescription you
get from the pharmacy. Even when a company is just considering an IND,
they have to be thinking about what the product's label will say.
Shannon does a lot of direct negotiation with FDA about labeling and
assists her clients with both early-stage and end-game labeling
matters.

The label is the ultimate piece of succinct writing, as it is the
final result of all those pages on the moving truck. Shannon writes
these herself because they require her previous experience with the
regulations that govern label content. Outside of this, most of the
work she does with regulatory documents involves reviewing and editing
the work of others.
What it takes to be successful in RA

Jobs in RA don't require a Ph.D. There are many RA associates in
regulated industries with undergraduate or M.S. degrees. People who
have jobs such as regulatory coordinator or regulatory associate are
involved in administrative activities, such as information management,
project tracking, or general support for the work that a manager or
director is doing on a submission.

Those in higher-level positions do tend to have doctoral degrees: a
Ph.D., an M.D., or both. It's the director of regulatory operations,
or the chief regulatory officer whose name is on the bottom line of an
important regulatory submission. That's a lot of responsibility
considering the cost of a new drug is $500 million to $800 million or
more!

But the real "must have" in RA isn't a degree, it's a desire to do
detail work. "It's something you either love or you hate," Shannon
says. "Anyone who has an interest in the regulatory field must have a
very pronounced love of detail. It has to be evident in what you've
done in the past and in your stated interests. While the regulatory
elements of a job like this can be learned, if you can't manage tiny
nuances of data in a multigigabyte document, you're in trouble."

Just about every job description these days calls for good
communication skills, but Shannon says it's a serious issue in RA.
"Nowhere in a company are written and oral communication skills more
important than in this career. Sometimes I'll have 30 seconds or a
minute to justify a recommendation with a busy CEO. If I can't
communicate my important message in that brief time, the project
doesn't move ahead. It's a completely unique field, one that stretches
every aspect of your communication ability every day."
Bring your passion as well

At the heart of an RA career is a belief that this work is being done
to help people, many of whom have life-threatening diseases. This
isn't work analyzing the genetics of a sea urchin; this is a job whose
daily mandate is to help sick people.

As we were closing our interview, I asked Shannon to tell me about her
original intent to make a difference in people's lives and whether she
had found what she was looking for. She paused a moment and then told
me about one of her proudest days at work.

"I had a chance to meet those whose quality of life had changed so
dramatically because of our project," she told me. "These were very
ill patients, bedridden, and who couldn't feed themselves. To see
their joy upon being able to sit up and eat on their own, ... it was
simply remarkable. It was an experience that I will never forget."

Photo (top): Guido E. Alvarez

A writer and speaker on career issues worldwide, Dave Jensen is the
founder and managing director of CareerTrax Inc., a biotechnology and
pharmaceutical consulting firm in Sedona, Arizona.

10.1126/science.caredit.a0900112