"Regulatory professionals...play many critical roles in bringing medical innovations to market, and the profession has proven resistant to industry downsizing," their latest report states on the RAPS website.
Regulatory affairs is responsible for testing medical products and drugs to ensure their effectiveness and their safety to patients and consumers. Clinical trials and research are managed by a variety of scientists, physicians, clinicians, medical laboratory professionals, and many more healthcare workers who work in conjunction with regulatory affairs professionals, who are responsible for ensuring that all products and pharmaceuticals are compliant with federal regulations for medical devices and drugs.
To learn more about this often overlooked sector of the healthcare industry, the Executive Director of the Regulatory Affairs Professional Society (RAPS) shared her extensive knowledge of the profession with About.com Health Careers.
Sherry Keramidas, PhD, FASAE, CAE answered the following questions regarding careers in Regulatory Affairs:
Q. Which Regulatory Affairs careers are in greatest demand currently? What skills and qualifications are needed most in the RA field?
A. There is a need for regulatory professionals at almost every job level, and particularly from specialist level up to VPs. The demand is evident across many different employment settings — industry (small and mid-size companies up to multinationals), government agencies (like US FDA, European Medicines Agency, etc.), clinical and hospital settings, universities that are involved in research and clinical trials, consultancies and clinical research organizations that run clinical trials.
Employers are especially in need of professionals with backgrounds related to the development, lifecycle management and/or regulation of healthcare products.
At entry level positions, employers are most often seeking staff who understand the health product sector and have some knowledge about regulations. They must do more than memorize regulations. Regulatory professionals need to know the pertinent regulations, of course, but they also must closely track regulatory changes and interpret the implications of the regulations to the work of their organizations. They need to be able to apply their knowledge and think critically. They also must be effective communicators, helping colleagues from other areas of their organizations understand the implications.
As they move up the career ladder, it becomes increasingly important for regulatory professionals to also improve their business skills (finance, marketing, policy, etc.) and be able to integrate their regulatory knowledge into business strategy and decision making, often on a multinational scale.
Q. What advice would you give to people who are interested in a career in Regulatory Affairs? Where should they begin, and how should they make themselves most marketable to employers?
A. Most people who make the transition into the regulatory profession have relevant prior experience working in related fields (e.g., research and development, quality or a clinical profession). Some may work in an organization that has a regulatory department. In such cases, it is helpful to connect and speak with regulatory colleagues and even seek opportunities to “shadow” them or be mentored. Employers are often looking for candidates who can “hit the ground running,” and take on real, complex regulatory work as soon as they’re hired. Gaining exposure to regulatory work from within an organization can offer an opportunity the gain some regulatory experience prior to making the official transition into the field.
Another important factor in being marketable to potential employers is Regulatory Affairs Certification — the RAC credential. The RAC is the only accredited, post-academic, professional credential for the regulatory professional working in the healthcare product arena.
The RAC is examination-based, with the exam developed based on the actual work of regulatory professionals. RAPS’ research shows that professionals who have the RAC credential earn more than their peers (about 10% more in North America), and are advancing in their careers. Some employers give preference to RAC holders in their hiring process, as it shows a level of understanding of the regulations, an ability to apply regulatory knowledge and a commitment to continual learning and knowledge enhancement (the RAC requires recertification every three years).
It’s important to note, however, that the RAC exam is intended for professionals with three to five years of regualtory experience, so for someone just getting into regulatory, it may be something to put into their career development plans for a few years down the road.
Q. What educational programs would you recommend for people interested in careers in regulatory affairs?
A. There are a number of options for those interested in getting into regulatory to help them build their knowledge of the regulation of healthcare products. RAPS offers numerous online courses that cover essential concepts of healthcare product regulation and regulatory issues at each stage of the product lifecycle and for different regions of the world. RAPS also offers a certificate in regulatory affairs for medical devices and/or pharmaceuticals, which is achieved by completing a series of these courses, and RAPS also offers a range of reference textbooks and other learning tools like conferences, webcasts, etc. Several universities also offer certificate courses or master’s degrees in regulatory.
Q. Why would someone be interested in a career in regulatory affairs? What are the best things about working in the RA field?
Regulatory is a challenging and dynamic field. The roles and responsibilities combine knowledge and skills from many different areas—science and technology, clinical fields, law, policy, business. For many people, this offers opportunities to expand and apply their knowledge and skills in new areas.
The dynamic aspects of the regulatory profession are also evident in how the profession has evolved with the changes in medical science and technology that underlie product development, increased globalization of the healthcare products sector and the changing needs of the public. And of course, ultimately, the regulatory profession is integral in bringing safe and effective health products to people around the world. It’s work you can really be proud of.
Q. What are some of the greatest challenges about careers in regulatory affairs? What is most difficult for job seekers and current RA professionals?
Among the greatest challenges are the diverse scope and breadth of the profession. To keep current and to grow, regulatory professionals need to focus on several different areas rather than one narrow area. This is also a positive aspect for many professionals. There tend to be a lot of gray areas in regulations, requiring careful analysis, scenario thinking and interpretation. While colleagues and executives may be looking for a simple clear-cut answer, this isn’t always possible; the implications of existing or potential regulations may be more nuanced.
Regulatory is also a cost center in industry and in some organizations, it has less influence than other areas including marketing and sales. However, increasingly, CEOs are recognizing the critical strategic value of regulatory expertise as a key component of overall business strategy. Finally, in developing regulatory strategy, regulatory professionals must take into consideration complex global dimensions, including multinational supply chains for product manufacturing, global shipping and sales, and various, differing marketing and postapproval surveillance requirements for multiple regions.
For job seekers who are already active professionals in other fields, they may face a challenge finding an opportunity to move into a regulatory position without regulatory experience. In some cases, they may have to accept a step down in title and compensation until they can demonstrate their abilities. A PhD laboratory director is not likely to move directly into a regulatory director position.
Q. Where do you see the RA field in five years, and ten years, from now? Will there be a significant shift in demand or do you think the current career trends will continue in terms of growth and demand?
It is difficult to precisely predict what the profession will look in five or ten years, but it has proven to be adaptable over the past couple of decades, so it’s reasonable to believe it will continue to adapt and evolve. Research that RAPS has conducted for over 20 years clearly shows that the scope of work of regulatory professionals has adapted to changes in science, business and regulation. The diverse body of knowledge that is the foundation of the profession and willingness of regulatory professionals to continue to expand their knowledge in many different areas may be a good indication that the profession will continue to adapt and grow.
The need and demand for safe and effective healthcare products is expected to grow over the next decades, driven by aging populations and increased longevity, the increase in chronic diseases, and greater general awareness of and access to healthcare products among people across the globe. The need and demand for regulatory professionals in regions where the profession is still nascent (Asia, Latin America, Middle East and Africa) is expected to grow tremendously in the next five years and beyond. The demand in North America and Europe should remain strong.
We expect regulatory professionals to become even more influential—both within their organizations and more broadly in efforts to improve healthcare and healthcare systems. The profession is already making important contributions to business and policy decisions, but the nature of the profession (its body of knowledge, scope of work and the education and continuing professional development of its members) should position the profession to be even more influential in the future.
Q. What else do you feel is important for current and/or future RA professionals to know at this time? Do you have any other advice, trends, etc., you would like to share with people who may be researching careers in the RA field?
A. This is an exciting and challenging profession that is also a “thinking” profession. To be successful the regulatory professional must be a strategic thinker who is willing and able to help colleagues—from researchers and engineers, to quality and manufacturing staff, clinical professionals, marketing and sales, financial and executive staff—understand the regulatory implications at every stage of the product lifecycle. In the past, in some organizations, regulatory professionals were seen as “roadblocks” to product launch and marketing. That has changed. They are more influential in the decision-making process now than ever, and executives have come to recognize the value of regulatory expertise in helping to avoid potential pitfalls. The regulatory professional is in a unique position as a guardian of public trust (ensuring government regulations are adhered to) and also as a guardian of the image and integrity of the organization he or she works for.