Summary: A Career As A Regulatory Affairs Specialist

Many different careers in the biomedical industry coordinate in order to optimize research and marketing goals. One of these careers is a regulatory affairs specialist (RAS). In the United States, regulatory affairs has evolved for over a century and has become a vital department within the biomedical industry. In the pharmaceutical industry specifically, an RAS plays a crucial role in certifying that a drug meets the safety and efficacy standards set by the government. Advanced education is necessary to enter into and keep up with the changing demands of the RAS career. The necessity for specialists in pharmaceutical regulatory affairs emerged as governments realized the importance of safeguarding patients. In the United States, the first …show more content…
In brief, an RAS in the pharmaceutical industry ensures that a company’s pharmaceutical products are safe and effective, and helps the company receive the appropriate licensing to market their products (Hogg, 2015). An RAS also ensures that all safety data from animal and human studies are reported, and that the final product labelling informs physicians and patients about the relative risks of using the product (Madhaven, Oakley, & Kun, 2008). In addition, the RAS also makes certain that efficacy data from human trials are properly documented for regulatory submission (Monahan & Babiarz, …show more content…
While most entry level jobs simply require a bachelor’s degree in a scientific field, advanced positions typically require a master’s or medical degree (Jensen, 2009). According to Jensen (2009), persons at the highest-level positions, such as “Director of Regulatory Operations”, typically have one or more doctoral degrees and decades of experience in lower-level positions. Employers in the pharmaceutical industry often prefer candidates who have graduated with pharmacy degrees (PharmD) over their bachelor of science peers (Hogg, 2015). Other than formal training, skills required for success in this field include: “Interpersonal communication and facilitation; writing, presenting, and speaking; [the] ability to simplify complex data sets; negotiation; interpretation and data analysis; team dynamics; project management; [and] information organization” (Guido and McEmber, 2008, p. 5265). In addition to formal academic training opportunities, there are multiple certification programs designed for an RAS. One such certification is offered by the Regulatory Affairs Professionals Society (“The New EU”, 2016). This society offers many online courses and textbooks for those hoping to enter this career