In a prior post, I promised to relate my research findings on getting either a certificate or a degree in regulatory affairs. Here is what I have learned.
Regulatory affairs (RA) personnel function in pharma and device companies to insure compliance with all of the regulations and laws within their business.
In a prior post, I promised to relate my research findings on getting either a certificate or a degree in regulatory affairs. Here is what I have learned.
Regulatory affairs (RA) personnel function in pharma and device companies to insure compliance with all of the regulations and laws within their business.
Typically these persons need to interact with Food and Drug Administration or European Medicines Agency. The functions overlap with clinical affairs and quality assurance departments. The activities are similar across several health industries including pharmaceuticals, medical devices, in vitro diagnostics, biologics and biotechnology products, nutrition and food safety, cosmetics and veterinary medicinal products. The regulatory process comes into play all along the development plan starting during pre clinical research and continuing through clinical trials, and in post market safety surveillance and monitoring.
What kind background and credentials do you need for a job in this field? According to Regulatory Affairs Professionals Society (RAPS)
“Most regulatory professionals have earned a bachelor’s degree, and more than half have an advanced degree, most often in a scientific or technical field. In addition, regulatory professionals usually have experience in other careers before transitioning into regulatory affairs.
Although there are some university degree and graduate certificate programs in regulatory affairs and related areas, experience is a key asset for regulatory professionals. Valuable skills include project management and organization, negotiation and communication, and the ability to learn from the experience of others, both inside and outside the organization.
Continuing education and professional development are critical to the regulatory professional. Regulatory professionals must keep up to date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of healthcare products.
For more information about the knowledge, skills and abilities of regulatory professionals, read the RAPS white paper, Regulatory Affairs Professional Development Framework: “An Overview or see The Regulatory Career Advancement Guide.”
Regulatory affairs managers typically earn $40-50 an hour, with some regional variation (between 90-100K per year).
So what is this RAC? It is the only certification specifically directed that training regulatory professionals for work in the healthcare product sector. RAPS states that …[the] “RAC credential is a professional distinction that denotes commitment to excellence, pursuit of knowledge and career advancement. RAC-credentialed professionals are among the current and rising leaders in the regulatory profession.” According to RAPS over 5000 credentials have been conferred on candidates.
Applicants must have a Baccalaureate degree (or equivalent) or 3–5 years regulatory experience, complete a certification program. Certificate programs cost between $4000 and $6000.
The candidate then must pass a standardized exam that takes two hours to complete and consists of 100 multiple-choice questions; administered at locations worldwide. The exam costs RAPS members: $325; late registration: $425; nonmembers (a fee that also covers one year of RAPS membership): $510; late registration: $610.
A list of institutions offer certification programs can be found @http://www.raps.org/your-career/resource-tools/degree-and-certificate-programs.aspx#us
There are also brick and mortar and on line Master’s degrees in regulatory affairs. These programs are needless to say more detailed than certificate programs. Typical master’s degree programs require 40 credit hours and cost between $300 and 500 per hour. Total costs range from $12K to 25K for a degree.
All listing of current degree and certificate programs can be found at:
http://www.raps.org/your-career/resource-tools/degree-and-certificate-programs.aspx#us
Job postings sometimes specify that a RAC is “desirable”. A posting may look like this:
Bachelor’s degree in a scientific or other relevant discipline required.
Advanced degree (e.g. MD, PhD, JD, PharmD) preferred.
Regulatory Affairs Certificate (RAC) desirable.
Minimum 15 years of regulatory and drug development experience in the pharmaceutical industry, including at least 10 years of management experience [Holy Sox! That is a whole heck of a lot of experience. With that much experience why do you need an RAC?]
Do you need an RAC? Do you need a Masters in regulatory affairs? Will it help you get a food in the door? Does the outlay of time and money improve your chances of landing a job?
I explored job boards, blogs, and called a couple of head hunters in this field and there is a consensus: high expense, low return on investment. Your degree, as one blogger put it, has a date stamp, and with regs changing all the time, your degree will lose “freshness”, and if you are not hired immediately, you will become stale very quickly. The tuition might be better spent on an MBA or other business degree. You will be paying $25K to hopefully improve you chance of landing an entry level job, a job with no higher pay grade than one you are qualified for right now. One recruiter I spoke to said that the only time she thinks a degree or certificate is worthwhile is if your employer will pay for it.
If not a degree or certificate program, how do you get from here to there?
Other paths do exist. Consider the following options:
The FDA also offers 100–120 preceptors working in the various FDA centers, which specialize in the evaluation of drugs, biologics, devices, food safety, nutrition and veterinary medicine. Persons who have FDA experience are seen as high value commodities in industry.
Take a job as an associate in Regulatory Department of drug or device company where you can learn about regulations and regulatory policy and gain exposure to the process involved in investigational New Drug Application (IND) & New Drug Application (NDA) and how the FDA interacts with companies. You will also be exposed to working on submissions for international agencies.
Work as a Clinical Trials Associate, Clinical Research Associate, Clinical Trials Manager to learn how sites governmental, industry and academic research sites interact with industry and with the FDA, and acquire hands on experience in data collection, document preparation and good clinical practices (GCP).
Find a fellowship or externship program with an institute or a company. Companies here and abroad offer opportunities often in conjunction with an academic partner. Novo Nordisk in EU offers a graduate program to help develop regulatory professionals. Biogen Idec offers a Regulatory Affairs/Safety and Benefit-Risk Management Fellowship, a Global Medical Affairs Fellowship, and Regulatory Affairs-Advertising, Labeling, and Promotion Fellowship. Many other firms have similar programs.
