Postdoctoral fellowships provide budding scientists with the advanced training necessary to prepare us for the next step in our careers. Traditionally, these fellowships are geared toward a future in academic research. For most of us, however, as I described in my first post, our career paths will likely take a different route. Recently, I suggested one alternative career option that utilizes our training: science writing. But for those who are not titillated by journalistic endeavors and/or prefer to work in a research-oriented environment that doesn’t involve bench work, I submit another possibility: careers in regulatory affairs.
Regulatory professionals protect the public health by evaluating the safety and efficacy of healthcare products and procedures before and after commercial release. Pharmaceuticals, medical devices, cosmetics and complementary medicines all fall under their purview. As highly skilled experts, they provide strategic operational support to expedite the development and delivery of safe and effective healthcare products around the world. In addition to playing critical roles in the development and approval of new healthcare products, regulators also maintain surveillance over these products to ensure compliance with applicable laws and regulations. Their duty is to advance, preserve and protect the public health.
Both government and non-government institutions employ regulatory professionals, who have origins in medicine, research, pharmacy, project management, engineering and manufacturing. Most people entering the regulatory field have prior experience in scientific and clinical research, and many have a degree in higher education – primarily in the life sciences or clinical sciences. Specialization by product type, such as medical devices, pharmaceuticals, biologics or biotechnology, is common. Furthermore, the regulatory professional development framework encompasses distinct domains that reflect the scope of responsibilities of the regulator, given their position. These domains include premarketing, postmarketing, interfacing, and strategic planning.
Premarketing occurs during research and development, in the preclinical and clinical phases of a new healthcare product. Regulatory specialists with backgrounds in toxicology, pharmacology, and the like help design preclinical protocols. Medical officers review investigational new drug applications and approve them for clinical trials. Regulators in the postmarketing domain administer inspections to assess compliance with government regulations and/or create the product’s promotional, advertising and labeling information. For example, interdisciplinary scientists at the FDA’s Center for Drug Evaluation and Research monitor drug production and distribution within the United States to ensure quality control of products. Those who work in the interfacing domain are heavily communication-oriented, as they interact with regulatory agencies, professional trade and standards organizations, and stakeholders. They represent the public relations specialists of the regulatory field. Strategic planning is applied throughout the product lifecycle and guarantees the integration of regulatory strategy and policy into the organization. Professionals at this level have a scope that is less technical and more tactical, as they expand and integrate their regulatory knowledge with business aspects of effective management and strategy development.
As you’ve probably gathered, there is no typical career path to regulatory affairs. While bachelors and masters programs in regulation exist, they are not requisite, as on-the-job training is customary. There is ample opportunity for advancement within regulatory affairs. Early career professionals are expected to possess skills in project management, writing, coordination, and communication. Their job is to develop basic knowledge and understanding of regulatory and legal frameworks, regulatory requirements, legislation, and the procedures and processes relevant to the profession. The Regulatory Affairs Certification (RAC) is the only certification specifically for regulatory professionals in the healthcare product sector, which is obtained by passing a rigorous exam. Obtaining the RAC is not critical for employment in the regulatory field (approximately 5,000 individuals have one to date), but it serves as recognition of professional achievement and is correlated with higher compensation and higher-level job placement.
To get started, I recommend joining the Regulatory Affairs Professionals Society (RAPS). There are currently 10 RAPS chapters within the United States and 15 international chapters. Membership dues range from $70-210, but are well worth the cost. Individual chapters organize events frequently to help aspiring regulators build a professional network and gain insight into global issues and advancements that play critical roles in the profession. RAPS offers educational opportunities including formal coursework with an emphasis on professional development. Students can elect to specialize in Medical Devices or Pharmaceuticals (or both) within the Regulatory Affairs Certificate Program. Additionally, the organization sponsors an annual meeting of regulatory experts, replete with workshops, exhibits, educational sessions and networking opportunities.
As postdocs, there are a multitude of alternative career options available to us that expand on our scientific training. Regulatory affairs lies at the interface of research and the public health, and professionals in this realm have an incredible responsibility to serve their community in a unique way. If protecting and advancing the public health appeal to you, consider a career in regulatory affairs.
Meghan Mott is a postdoctoral fellow at the National Institute on Alcohol Abuse and Alcoholism where she studies neuromuscular disorders and gene therapy using zebrafish as a model system. Originally from Louisville, Kentucky, she earned her BA in biology at the University of Chicago and PhD in Anatomical Science and Neurobiology at the University of Louisville where she studied cytokine genetics and expression in Autism Spectrum Disorders. She is current with the difficulties PhDs in the life sciences are faced with in career academia and as co-chair for the NIH Fellows Committee on Career Development, she hopes to further the awareness of non-academic career prospects for post-docs. For more information on Meghan, please visit her Linkedin page: http://www.linkedin.com/pub/meghan-mott/42/326/5b4 or email her at: [email protected].
The author’s views are her own and do not represent those of her institute or NIH.
Original source: http://www.postdocsforum.com/2012/03/15/alternative-careers-for-science-phds-part-ii-regulatory-affairs/