Martha Feldman never wanted to be a regulatory affairs associate. But once
she got into the field, she never looked back.
"When I was growing up, women were encouraged to be nurses, not doctors,
which is what I wanted to be," says Feldman.
Feldman got a teaching fellowship for graduate school, where she majored
in one of the life sciences. She currently works for a drug and device development
business in Washington.
She says she "slipped into" this field through the clinical research area.
She wrote reports for the FDA on the clinical research. As time went by, she
wrote more and more for the FDA. Along the way, she learned more about the
product approval process.
Being in regulatory affairs has turned out to be a positive move. "This
approach has offered me a chance to participate on the periphery of medicine.
I've been helping hundreds of thousands," she says.
"As a doctor, I would have treated maybe 1,000 people in my lifetime. I
believe I would have wound up doing this type of work anyhow, even if I had
become a doctor."
She says the most challenging part is developing the regulatory strategy
for a product. "In so many situations, the path to approval is not clear.
It is up to the regulatory professional to work with others to determine the
best, most logical, most cost-efficient pathway."
For example, imagine a bandage that has been treated with an antibiotic.
It will be regulated according to its purpose. It might be a medical device
or a drug delivery system.
"The difference can mean hundreds of thousands of dollars spent on clinical
studies," Feldman explains.
She says she's amazed by the ingenuity of those who develop new products
or create new uses for old ones. "After all," she says, "how many centuries
was the pie tin around before someone turned it over and wrote Frisbee on
it?"
Larry Gundersen is the head of San Diego State University's regulatory
affairs program. When he was a PhD student, he didn't want to end up
in teaching or lab work.
"A career in regulatory affairs presented itself," he says.
Gundersen saw it as a way to use his scientific training, satisfy his interest
in communications, and make a meaningful contribution.
He says the fun and challenge of this career is in the problem solving.
Part of the job is to help the company in complying with FDA laws and regulations.
These workers must "be able to do so in a manner that is practical," he
says.
"This requires a detailed and up-to-date understanding of the regulations,
an understanding of the company's products and capabilities, and some
creative, strategic problem-solving abilities."
Gundersen enjoys this profession because he likes being part of a team
effort. "I also enjoy the challenge of having to learn new information about
new subjects. Regulatory affairs involves both of these activities," he says.
"And the final product of all the work involved in these efforts is a new
drug which may be able to alleviate the suffering of a fellow human being.
That is pretty rewarding."
He adds that this profession has given him a job where he is anxious to
go to work each day.
What advice does he offer students interested in this field? "The old humorous
answer to the question, 'How do I get to Carnegie Hall?' is 'Practice,
practice, practice!' For the regulatory affairs professional, the answer
is 'Study, study, study!'"
For those who enjoy science and math, he says it's an alternative
to working in a lab or becoming a doctor.
"See if there is an opportunity to meet someone already working as a regulatory
affairs professional to learn more about what they do and how they like their
work."
Tom Bindon has worked as a lobbyist in this field. Now his company works
as a mediator between his clients and government.
"The most challenging thing that I find, outside of competition, is trying
to make the government understand the message."
He says taking that first step to introduce a company or their product
is the most challenging.
"The most rewarding thing is when I see it all come together. You see job
creation and economic growth as a result."
According to Bindon, job growth in this area looks good. "There [are] all
sorts of issues that are playing out between the government and the private
sector. There's a big need for people to help government understand where
industry is going."
Bindon says a big reason that students might want to get involved in regulatory
affairs is because they want to make a difference. Two growing areas of concern
are technology and the environment.
"Lots of kids are concerned about the environment -- air quality, water
quality," says Bindon. "You can be working with people who are
working with environmental policy, developing safe environmental standards
and regulations to reverse some of the damage that we've done."