Pharmaceutical regulatory affairs specialists serve as the bridges between a drug's conception and approval. According to Corinne A. Marasco, C. Washington and E.N. Washington of Chemical and Engineering News, "the pharmaceutical industry is the most regulated of all industries" and it's the regulatory affairs specialists who see that those regulations are met. Their work has wide ranging implications. Not only is it their job to protect the health and safety of the public, but to navigate the drug company's business plan, the government's continually changing drug policies, the ethics of pharmaceutical production and interests of the medical research community.
Pharmaceutical regulatory affairs specialists manage all the red tape surrounding a drug's successful approval and release. They coordinate with scientists and pharmaceutical officials to plan drug trials, facilitate drug research and interpret and report data to regulatory agencies. They make sure all activity that occurs within a drug's lifespan meets state and federal guidelines. They apply for all necessary approvals and marketing permits from the FDA as well as international regulatory offices, and track, obtain and renew any required permits and licenses. These duties can be as broad as setting up a drug trial or as minute and specific as indicating what information must appear on a drug's label. Any activity that falls within the realm of a drug's approval is fair game for a regulatory affairs specialist.
In order to work as a pharmaceutical regulatory affairs specialist, most companies require a minimum of a Bachelor's Degree in science, preferably in pharmacy, pharmacology, chemistry or pharmaceutical technology. Because of growth in the field, there are at least six universities now offering Master's Degrees in pharmaceutical regulatory affairs. In addition to the right kind of education, most applicants will be required to have a minimum of three years of experience in a clinical or research role that includes working with new drug applications and pharmaceutical protocols. Although most companies have stringent application requirements, according to DOCS International Pharmaceutical Staffing Agency, there is still room for those without pharmaceutical related degrees who have experience or on the job training.
Necessary Skills and Traits
Because these positions are so complex and involve so many different responsibilities, pharmaceutical regulatory affairs staff must be exceptionally organized and pay alarmingly keen attention to detail. One oversight can have detrimental effects on public safety and can delay a drug's release. The position also requires a strong command of the English language as it relates to writing reports and regularly and effectively communicating with regulatory agencies. There's a great deal of paperwork, both online and off, involved in a drug's conception through its approval. Specialists must be able to assemble, guide and participate in a team, but also work well independently. They must also be able to handle the stress of tight deadlines and a fast paced work environment.
Regulatory affairs professionals posses a highly specialized set of skills and perform complex tasks on a daily basis. Because of this, they are generously compensated. According to salary reports gathered by Salary.com and PayScale.com, entry level regulatory affairs specialists make from $40,000 to $60,000 per year. Those with an average to above average level of skills and experience can earn a median level income of around $98,000. Those in high-level positions with managerial responsibilities and advanced degrees can earn up to $150,000.
There are conflicting reports on the outlook for jobs in the pharmaceutical agency. According to a study called "The Continuing Evolution of the Pharmaceutical Industry: Career Challenges and Opportunities," by Regent Atlantic Capital and Fiduciary Network, the pharmaceutical industry is expected to lose over 50,000 jobs over the next decade due to decentralized business practices, outsourcing to private labs and universities, more stringent government regulations and potential economy-driven profit loss. However, they also state that because the priority will still be to get drugs on the market as soon as possible, regulatory affairs careers will be least affected by this change and will remain in high demand.
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Regulatory Affairs byCorinne A. Marasco, C. Washington and E.N. Washington
The Continuing Evolution of the Pharmaceutical Industry: Career Challenges and Opportunities
Sample Regulatory Affairs Job Description