STUDENTS FREQUENTLY ASKED QUESTIONS
What does the job market look like for RA professionals?
According to Industry Canada1, the Canadian pharmaceutical industry is comprised of innovative and generic firms including multinational subsidiaries with R&D and manufacturing mandates, and employment was estimated to be almost 60,000. There was expected growth, specifically, with the emergence of fully-integrated pharmaceutical companies, a growing biopharmaceutical industry, and a growing contract research and clinical trials industry. As these areas are regulated, the job market also looks bright for RA professionals, in spite of the recent recession.
What would be the profile of a good RA candidate?
In addition to relevant scientific and pharmaceutical background knowledge about the types of products, drug development, and regulations, which can be obtained through regulatory courses or scientific degree programs, there are somesoft skills and competencies that are generally considered beneficial for a good RA candidate. These include strong communication skills (both written and oral), for preparation of regulatory applications and any negotiation that may be required. Strong project management skills are usually considered necessary, since they're needed to keep track of all required information and timelines for submissions. Attention to detail and strategic thinking skills are also often considered an asset, to ensure that all regulatory requirements are met but that they are met a manner that is best suited to the company.
What does it take for newcomers to break into the industry?
There are many ways that RA professionals have entered into the industry. Many RA professionals have university backgrounds, including post-graduate degrees. In recent years, there have been post-graduate programs specifically designed to provide RA training. Some of these programs have Co-Op options, which allow for newcomers to gain on-the-job experience, directly working for potential employers. Other newcomers to RA have gained relevant experience in other areas in the industry, such as quality assurance, manufacturing, clinical development and medicine, toxicology or pharmacological research. Of course, networking with CAPRA members through volunteering or attending CAPRA events such as Dinner Meetings can never hurt!
What types of roles to RA professionals have within industry?
RA professionals may work within industry for a company that sells or develops regulated products (eg, for a Sponsor). They may also work for consulting companies or as part of contract research organizations that provides RA services for a Sponsor company. Of course, regulators working for the government agencies (eg, Health Canada in Canada, the Food and Drug Administration in the United States) are RA professionals too. In general, the role of this RA professional is to keep abreast of the ever changing regulations, communicate requirements to Sponsors, and help to ensure that the therapeutic health products being used by people are manufactured, tested, and labeled so that they can be used safely and effectively.
How does RA fit within a company in industry?
For companies that wish to sell or develop regulated products such as pharmaceuticals, biologics, medical devices, cosmetics, natural health products, etc., applications generally have to be filed to the government and products authorized prior to their use. Many companies within industry will have a RA department that is responsible for such filings, while those that don't generally rely on external RA professionals to either file these applications or communicate the requirements for development, sale or investigational human use. These applications generally include information on how the product will be used (eg, labeling and marketing materials), how it is made (eg, manufacturing), and how it was shown to be safe and effective for use in humans (eg, nonclinical and clinical testing). Although RA professionals are not generally responsible for generating this information, they may work with any or all of the departments who will provide the information for regulatory applications. RA professionals may also work closely with quality assurance to obtain appropriate documentation and to ensure compliance of the testing that is conducted (eg, under GXPs).