Competition for quality job candidates in regulatory affairs has been fierce in recent years. That means pharmaceutical companies, clinical research organizations, consulting firms, and others in the pharmaceutical and healthcare device industries need to exercise care when deciding who to hire. Read on to find out how to evaluate candidates and determine what makes someone stand out.
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Knowledge of the Field
Any employer’s top priority should be to find a candidate that is highly knowledgeable in the field, and regulatory affairs are certainly no exception. If anything, the expectation should be that candidates have a greater level of specialized knowledge, which is why employers work with Executive Regulatory Affairs Professional Search firms rather than general recruiters. For entry-level laboratory jobs, a degree in science and a desire to learn is sometimes considered sufficient, but that can’t be the case for regulatory affairs.
A regulatory affairs professional needs to have a solid working knowledge of the laws that govern medical products and an understanding of how the regulatory submission process works. For pharmaceutical companies and researchers testing new medications, an understanding of the drug development process is also a necessity.
Critical Thinking
There’s little use in having even a deep understanding of the drug development and regulatory affairs landscape if a candidate can’t synthesize all of that complex information so that others can understand it. Critical thinking skills underlie the ability not just to understand what’s going on in product development but also to find ways to translate that information into language that other people will understand.
Writing Skills
Because regulatory affairs experts are typically responsible for producing multiple types of long-form documents, their writing and review skills must be on point. Types of documents prepared by regulatory affairs professionals often include:
- Due diligence reports
Reviews of protocols
Documentation of efficacy, quality, and safety
New drug applications
There will also be all types of additional reports to submit throughout the development process. While these documents tend to be highly structured, it takes both generalized linguistic skills and more specialized knowledge of scientific writing and legal requirements to produce them.
Oral Communication Skills
Regulatory affairs often function as representatives not just to internal employees but also to external parties, so they need to be persuasive, effective communicators. In many cases, fluency in a second language can be an asset, as well. The candidate will need to establish good relationships with manufacturers, marketers, and regulatory authorities in addition to those working within the product development lab.
Organizational Skills
Finally, a good candidate for an open regulatory affairs position will possess excellent organizational skills. They’ll need them to coordinate application procedures, develop realistic action plans, and keep up with the many types of work activities required of them in daily life.
How to Find the Right Candidate
The best way to find a good candidate for an open regulatory affairs position is to work with a highly specialized recruitment firm. For those who want to fill executive-level positions, having the right recruiter is even more essential, as these regulatory affairs leaders will be tasked with overseeing other less experienced employees in addition to making good use of all of the skills described above. It’s never worth cutting corners on the search for a new regulatory affairs leader, or even for someone to fill an entry-level position.
