Daniela Drago, director of the regulatory affairs program at The George Washington University, offers advice for those considering a career in regulatory affairs.
As director of the regulatory affairs program at The George Washington University, Daniela Drago oversees the university's certificate and master's degree programs in regulatory affairs. She has held managerial positions in global regulatory affairs for small and medium-sized companies as well as at multinational life science companies. Here, she offers advice for those considering a career in regulatory affairs.
Will I find regulatory affairs/science interesting?
|Interested in regulatory affairs? Register for the Quality Control, Risk Management, and Regulations conference track at MD&M Chicago, September 10–12, 2013.|
The work of a regulatory professional is diversified and dynamic. The profession offers a unique perspective of various aspects of the development and commercialization of healthcare products (i.e., medicines, medical devices, cosmetics, and nutritionals). For example, in a typical week a regulatory professional working in industry might interact with colleagues from sales, marketing, research and development, and production. The regulatory professional will sit on a crossfunctional team that reviews carcinogenicity results, clinical protocols, manufacturing batch records, and promotional material. The team’s activities will make an impact on patients, public health, and the company’s bottom line.
Will I get a job?
Companies, governmental agencies, clinics, hospitals, and universities seek candidates who understand the regulatory world. Jobs in regulatory affairs/science are available in the United States and internationally. Generally there are more vacancies than qualified applicants. Highly sought-after candidates are team players. They can combine strategic thinking with effective negotiation and communication skills. Talented regulatory professionals don’t stay long on the job market.
Will I see a growth in demand?
The healthcare industry is expected to grow, especially in emerging markets. This will result in an increased demand for skilled regulatory professionals. Currently harmonization efforts are underway to streamline regulatory requirements and processes (e.g., ICH and IMDRF). However, there is still a high variation across national borders and between segments of the industry. Therefore the need for well-trained regulatory professionals is likely to increase. This will occur not only in the United States and western Europe, but in Latin America, Asia, and other “pharmerging” markets. Undoubtedly, those with a broad knowledge of global regulations who can work effectively in an international environment will have a competitive advantage.
What challenges can I expect?
Keeping your knowledge up-to-date, especially in such a broad and diverse function, can be challenging. Professionals in this field must closely follow changes in regulations and effectively interpret and communicate their implications. They must also establish and maintain collaborative relationships with regulatory bodies in order to be able to provide safe and effective quality products to consumers and patients.
How do I transition into a regulatory role?
Traditionally, regulatory affairs has been a field in which individuals would enter from related areas and get on-the-job training. In the past few years, however, academic and certification programs in regulatory affairs have flourished. State-of-the-art online programs, designed to meet the needs of busy professionals, can be a useful way for individuals to enter or advance in the field. People considering higher education should seek out a program that has a good reputation. The program also must have an academically rigorous curriculum that meets the constantly changing needs of a dynamic profession.
Daniela Drago is an assistant professor of clinical research and leadership at the School of Medicine and Health Sciences at The George Washington University.
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