Turning that science minor into a major career

A background in basic science - whether it’s undergraduate minor in biology or an existing job in a bioscience industry - can be a great base for launching into a spot in San Diego’s bioscience and pharmaceutical hub.

 

“We have a real need for people with a basic understanding of science and good specialized training,” says Biotech Employee Development Commission board member Kathleen McGinley. “We have big companies here that bring people in at entry level as well as smaller, highly specialized companies that contract their clinical studies, regulatory affairs and analysis.”

 

Regulatory affairs, making sure that drugs, treatments and devices are meeting U.S. Food and Drug Administration standards while they are being developed, is a growth area in the regional biotechnology and life science hub. And the job is portable to other areas, like the San Francisco Bay Area and Boston and North Carolina, and other biotech hubs.

 

Many people come to regulatory affairs from inside their current companies, often with experience in quality assurance, says Steven Kradjian who teaches regulatory affairs classes at the UC San Diego Extension.

 

“In regulatory affairs, a scientific background is very helpful, but it’s not required in the field,” Kradjian says. “A person should have great written communication skills, be very diligent and detail-oriented, should be able to recognize where details fit into the big picture.”

 

From the beginning of development to the time products reach the market, products go through phases of regulations that become more stringent as they get closer to human use.

 

“There’s a certain level of compliance with each phase and it’s naïve to adopt a great deal of structure prematurely,” Kradjian says. “It’s also a mistake to not have compliance in place every step of the process.”

 

People in the field have to stay very current on the regulations and how to apply them because they change as the science advances. Regulations for stem cell research will certainly evolve in the next five years, for example.

 

“You work in a heavily regulated environment, so it’s good business to understand the applicable regulations and the FDA expectations,” Kradjian says. “Smart companies see the value of having someone advising on how to navigate so you’re appropriately compliant without overdoing it.”

 

The work includes documenting that guidelines and regulations have been met, compliance auditing, preparing detailed submissions to the FDZ and what Kradjian calls pathway analysis.

 

“We determine and advise companies what steps they have to take to expedite development, while maintaining prudent levels of compliance,” he says. “There isn’t always just one answer but there’s always a best answer.”

 

“The best of us are very good at anticipating questions that will be asked and thinking through the coming issues before the regulatory agency is asking,” he adds.

 

Conventus Bio Medical Solutions, where Kradjian works, often takes a team approach to projects for bioscience and pharmaceuticals, but not medical devices. Many small bioscience development companies hire firms like his to guide their relationships with the FDA rather than try to support in-house staffs. Larger companies, like Amylin and Pfizer La Jolla Laboratories have their own regulatory affairs groups.

 

The firm has an internship program and has recruited a number of graduates from the UCSD Extension professional certificate program (www.extension.ucsd.edu/lifescience ).

 

“I teach in order to grow the pool of trained talent in the industry,” Kradjian says. “There is a demand for people at all levels of their careers, from entry level to senior management.”

Tags: SDNN

This entry was posted on Wednesday, July 1st, 2009 at 10:39 am and is filed under Job & Careers. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.