Regulatory Affairs Manager – A Day in the Life
For every dollar that American consumers spend, 25 cents goes towards a product or service regulated by the Food and Drug Administration (FDA). Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations. With these rules constantly changing and new ones being introduced, it’s no surprise that over 30 percent of organizations increased their regulatory staff in 2017, according to an industry report, and over half of all organizations expect to hire additional staff in the coming year.
Regulatory affairs is a multidisciplinary field requiring a skill-set that’s both broad and deep. The scope of work involves a complex combination of economics, science, public policy, law, and health. To be a successful regulatory affairs manager requires attention to detail and the ability to speak the language of several different fields.
While they can work in a wide variety of different settings, all regulatory affairs managers have a unified goal: to manage the commercialization of safe and effective products. To get a broader, deeper understanding of a day in the life of a regulatory affairs manager, read on.
Work Environment of Regulatory Affairs Managers
Regulatory affairs managers can work in a wide range of different sectors, but the majority (41 percent) work primarily with medical devices and 27 percent with pharmaceutical drugs.
In total, over three-quarters of regulatory affairs managers work directly in a regulated industry. The rest work in consulting, in academia, or for research and marketing firms. While regulatory affairs managers primarily perform their duties from an office, that’s just a hub of operations for a job that’s centered around communication.
Regulatory Affairs Clinical Team
The scope of a regulatory affairs manager’s work stretches across several departments, requiring interaction with research and development, marketing, and senior management. Frequent communication between these silos is critical in maintaining adherence to regulations, staying abreast of what’s due to change, and shaping a unified strategy that meets a company’s overall goals.
But internal work is only part of the job—about a fifth of one’s time is spent on regulatory intelligence and strategy-based tasks that require one to look outside of the parent organization.
Regulatory Affairs Responsibilities
There is no typical day for a regulatory affairs manager. Much of their work is project-based and dependent upon what stage of the product life cycle the employing company finds itself.
The tasks of a regulatory affairs manager could be lumped into two broad categories: strategy and operations. Strategy involves the regulatory outlook for a company in managing their product line and marketing, while operations is the nuts and bolts of product development. In practice, however, the line between these two categories can blur, particularly in a task such as label design.
Typical daily responsibilities of a regulatory affairs manager include:
- Writing evidence-based reports on a new product
- Writing executive summaries of new or changing regulations
- Interfacing between R&D, marketing, and senior management
- Interpreting both scientific and legal documents
- Developing regulatory strategies and implementation plans for new products
- Overseeing product trials and regulatory inspections
- Obtaining marketing permission for a new product
- Outlining requirements for a product’s labeling, packaging, and storage
- Writing concise, clear, and informative product information leaflets
- Overseeing the completion of all regulatory compliance documents
Required Skills & Education in Regulatory Affairs
Close to half of all regulatory affairs managers have academic backgrounds in the life sciences, and while finding work with a bachelor’s degree is possible, a master’s degree (or higher) is increasingly preferred. Some regulatory affairs managers even hold PhDs that allow them to understand all aspects of a product’s lifecycle, from research and development all the way through testing and marketing.
Ultimately, experience has more of an impact on compensation than the level of academic degree completed and precise employment requirements will vary based on a particular product or industry.
As for soft skills, communication is a regulatory affairs manager’s most critical asset. The ability to interpret regulatory legalese through a strategic business lens—then translating that into a form that scientists can understand and back again through the pipeline—is a crucial aspect of the job. Speaking of translation, over 74 percent of regulatory affairs managers based in the US have multi-regional or worldwide responsibilities, according to a 2016 report, and that number is set to increase, making secondary language skills and international experience a highlight on regulatory affairs managers’ resumes.
Whether combing through dense regulatory documents or vetting pharmaceutical strategy, attention to detail is key. Regulatory affairs managers have to be slightly obsessive about the little things in order to perform their job well. And, conversely, they need to keep one eye on the big picture if they want to optimize their company’s strategic outlook. Straddling those lines between micro and macro, between science and business, is the bailiwick of regulatory affairs managers.
Regulatory Affairs Certification
In an industry as wide and nuanced as regulatory affairs, the most definitive way to establish one’s expertise is to earn professional certification.
The regulatory affairs certification (RAC) from the Regulatory Affairs Professional Society (RAPS) is the gold standard. RAC holders earned 11 percent more than their non-RAC holding colleagues in 2016, and 17 percent more in 2017. Applicants can pursue certification based on contextual criteria: geographic region (US, Europe, Canada, or global) and product type (medical devices or drugs).
In order to be eligible for any of these certifications, applicants need one of the following:
- Bachelor’s degree and three years of regulatory work experience
- Master’s degree and two years of regulatory work experience
- PhD and one year of regulatory work experience
Once deemed eligible, candidates can take a 100-question qualifying exam. Questions fall into three formats: recall, application, and analysis. To successfully pass the test, candidates must prove their fundamental understanding of regulatory functions throughout a product’s lifecycle, as well as the governing guidelines and standards of their domain. The exam fee is $475 for RAPS members and $595 for non-members.
RAC holders must complete 36 hours of continuing education every three years in order to renew their certification.