Monday, July 11, 2011

Are you not sure about regulatory affairs career? you will get the answer here..

The Regulatory Affairs Professionals Society describes this field as "vital to making safe and effective health care products available worldwide," but this indistinct description fails to capture the true character of this satisfying occupation. Although regulatory affairs careers are diverse, the career paths and views of the two regulatory professionals described below will help illuminate the nature of regulatory affairs careers.

She started her career in synthetic organic chemistry. After completing her graduate degree at _______ University in Baltimore, Maryl and, she was hired as a senior research scientist at the research and development (R&D) unit of Smith Kline & French Laboratories (now GlaxoSmithKline). After a few years, she realized that "basic research was too narrow a scope within the pharmaceutical R&D arena" for her interests. She navigated through the pharmaceutical R&D sector until she reached her current position as head of regulatory affairs at the biotech company Centocor.

In addition, these scientists agree that knowledge of the regulatory process, laws, and policies generally does not require formal training. Scientists entered the area of regulatory affairs from pure science backgrounds and attribute their extensive knowledge in those other fields to years of on-the-job training as they worked at different levels of their respective companies.

She says, "I took a systematic approach by taking positions in my career in departments such as clinical R&D and project and portfolio management, so that I could maximize the opportunity to gain in-depth knowledge of every step of the R&D process." Those past experiences have been essential for the regulatory position she now holds.

It is the continued learning process to keep current with the latest scientific and regulatory developments. In order to excel in regulatory affairs, it is necessary to be knowledgeable about the latest scientific developments and discoveries, as well as about current regulatory laws and policies.
Although maintaining a high level of expertise in so many areas may be exceptionally demanding, that is exactly what these scientists enjoy. So many employers considers communication and organizational skills to be paramount. She also relies on these skills in managing her staff and directing the scope of regulatory strategies of Centocor. Communication is crucial in regulatory affairs, as there must be a clear and open dialog between lawmakers, the regulated companies, and consumers, for whom the entire process was designed.
According to she, moving in and out of regulatory affairs is relatively easy. The scientific knowledge and skills needed in regulatory affairs, she explains, are similar to those needed in other scientific jobs. Jones has recruited scientists from many different backgrounds, including chemical development, clinical R&D, preclinical/toxicology, and information management.
Most of the professionals can agree that scientific training, communication skills, and the desire and drive to continue learning are essential. In addition, these scientists illustrate that the regulatory field draws upon a variety of skills. Finally, and most importantly, people can demonstrate that careers in regulatory affairs can be rewarding.
Many Career Paths Lead to Regulatory Affairs:

The regulatory affairs (RA) field comprises a diversity of disciplines. Individuals who ensure regulatory compliance and prepare submissions and people whose main job function is  clinical affairs or quality assurance are all considered Regulatory affairs professionals.
These individuals can have careers in private industry or the government and work with a wide range of products such as medical devices, pharmaceuticals or biologics etc.

Regulatory affairs (RA) professional background:
RA professionals can come from diverse backgrounds. No set educational or career path must be followed. Although several university programs are being developed, there currently are only limited opportunities to earn an advanced degree in regulatory affairs. In regulatory affairs many of the individuals can be moved between areas of regulatory affairs, for example, starting in clinical affairs and transferring to regulatory submissions. 

Educational Background

If you look at the classified ads in Regulatory Affairs Focus, you see that a bachelor's degree is required for most positions. When a specific educational background is noted, most companies require a degree in a scientific or technical field. 

Does your educational background affect your performance as a regulatory professional?
It depends on whom you ask because most of the companies prefer to choose candidates with special knowledge which greatly assists to the employers in performing their daily functions. Likewise, regulatory professionals in the pharmaceutical or biotechnology fields may be more likely to have a background in one of the sciences such as biology or chemistry. Some companies lean toward hiring nurses and clinicians in their clinical affairs departments. 

Although many RA professionals are likely to have a degree in a scientific or technical field, a specific educational background does not appear to guarantee a successful career in regulatory affairs. Whereas a degree in engineering or the life sciences may seem more applicable to most regulated industry positions.


No specific degree or career path ensures success in the regulatory profession. No college degree or basic seminar can "make" an RA professional - the title is earned through experience and hard work. 


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