Rules Rule

Regulatory affairs is a young profession that's already making its mark in the world of drug development, where one false move can bring years of research to an unwelcome end. If your skills include communication and leadership, it may be for you.

Last year, global spending on prescription drugs exceeded US$600 billion. Topping the sales list were drugs to combat high cholesterol levels, heartburn, schizophrenia and asthma. But regardless of their sales strength, every drug had one thing in common: each had been scrutinized by regulatory-affairs professionals before reaching the pharmacy shelves. Employed by the drug companies and contract research organizations, these experts assemble huge dossiers of data and oversee the mountain of paperwork required by the regulatory agencies that oversee the industry."The basic responsibility is to interpret the regulations and guidelines of the different regulatory agencies,".Regulatory-affairs professionals are an essential part of the drug-development process, and jobs in the field typically crop up wherever there is healthy investment in R&D. These professionals have a vast scope. They prepare, submit and monitor submissions to regulatory agencies, and get involved in manufacturing, labelling, marketing and post-marketing activities. Increasingly, their involvement begins during the R&D phase, where they help smooth the transition from drug development to clinical trials.

Once a company identifies a promising compound, a regulatory-affairs team begins drawing up the plan that will guide the compound through development, clinical trials and onto the shelves. "We work with the scientific team during the preclinical phase to make sure that we have the right data," says Lisa Skeens, vice-president of regulatory affairs at Baxter in Deerfield, Illinois. "We are the liaison between the regulatory authorities and the company, the experts in understanding the regulations and the guidelines. We know through experience what the global regulatory agencies expect."

Preparing for the move

People come from all kinds of backgrounds, says Joseph Scheeren, head of global regulatory affairs at Bayer HealthCare's pharmaceuticals division in West Haven, Connecticut. Some join regulatory affairs immediately after finishing their education; others make internal moves from development or discovery, he says. New recruits can expect to receive a lot of mentoring and coaching during the first two years of their job. Regulatory professionals with experience in a specific therapeutic area are especially appealing to companies that are expanding into new areas.
Today's professionals see regulatory affairs as a career that offers continual learning and interaction with scientists and regulators. And with harmonization, changing regulations and the constant expansion of the therapeutic realm, it's never dull. "I've been in the regulatory-affairs area for almost 25 years, but I learn every day," says Scheeren.

Article Source:Nature