April’s Regulatory Focus: Professional and career development

Feature ArticlesFeature Articles | 03 May 2021 | Citation

Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Included were articles on the mid-career transition from research scientist to regulatory professional, continuous professional development and the value of graduate-level qualifications, and findings from two surveys on different aspects of the profession. Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products.  
Continuous professional development
Many in the regulatory profession have transitioned from an established previous career such as engineering, law, or bench research. In The PhD scientist’s pathway into regulatory affairs, Laura DiMichele, PhD, RAC, CCRP, examines how the combination of an advanced science degree, transferable skills, and established professional experience can facilitate such a shift for the life and health science researcher. Although it is difficult to gain regulatory experience in an academic or industry research setting, DiMichele asserts that the skills and training a PhD scientist acquires during graduate studies provide a valuable foundation for a career in regulatory. The best way for a research scientist to enter regulatory is through industry, writes DiMichele, although some internships and fellowships are helpful as well. The article includes valuable information on some of the available programs.  
In  Value of an RA qualification in continuous professional development and career progression, Olivia McDermott, PhD, MSc, MBA, CSSBB; Deirdre Barrow, MSc, HDipl, and Mary Butler, MSc, HDipl, report on the findings from a qualitative and quantitative study on the advancement and experiences of industry-based graduates who completed a master’s degree in regulatory affairs at a university in Ireland. The results demonstrate that regulatory knowledge and qualifications are an advantage and of value in personal and professional development. Moreover, they suggest that organizations likely place a value on graduate courses in regulatory because they tend to promote and improve progression opportunities for employees who complete the courses.
Surveys and profiles 
Who is the average regulatory professional? The biannual RAPS 2020 Global Compensation and Scope of Practice Report analyzed responses from nearly 2,000 regulatory professionals worldwide in an attempt to answer that question. In The regulatory profession by the numbers: RAPS’ 2020 compensation and scope of practice survey, Randolph Fillmore reviews the report’s main findings, focusing on regulatory professionals’ levels of education and certification, experience, the most common regulatory functions performed, and career and job motivations. Regulatory professionals, we find, are an impressive group. To begin with, they are highly educated – most have a master’s degree – and many have entered the profession with a number of years substantive experience in a previous career. Once they are established in their new professional track, they work mainly in regulatory strategy and/or submissions, and yes, they are RAPS members and hold the Regulatory Affairs Certification (RAC).
Regulatory intelligence has gained significance in recent years, especially with the increased complexity of products and implementation of technological innovations, write Daanish Ashraf, PharmD, and Kirsten Messmer, PhD, RAC, in Evolution of the regulatory intelligence profession. The authors provide an overview of the evolution of the regulatory intelligence profession over the past 2 years and examine its possible trajectory during the next 5-10 years. They suggest that with the challenges, the need for using developing technology – particularly artificial intelligence, natural language processing, and machine learning – becomes more prevalent. Despite this greater need, the regulatory intelligence function currently remains small, independent of company size, which underpins the need for implementation of evolving technology to support the regulatory intelligence team. 
Effective communication
The ability to confidently convey an idea and persuade others of its benefits is key to personal and organizational success, writes Nancy Singer, JD, LLM, RAC, FRAPS, in Talking to decision makers: What to say and how to say it. But having a good idea is only half the battle, warns Singer, as she discusses ways to develop and use persuasive skills, providing a detailed, step-by-step template for preparing a short, 30-second persuasive pitch. Physical presence, maintaining eye contact, facial expressions, speaking tone, and  maintaining a positive attitude are all components of effective persuasion.
Regulatory intelligence activities are complicated by the push for stronger product sales in emerging markets. In Communication of regulatory intelligence: A survey of the medical device industry, Martha Kamrow, PhD, reports on her research into on how medical device companies structure their regulatory intelligence operations and communicate that information to other parts of the company. The findings suggest that two-way conversations or discussion are the preferred method of communicating regulatory intelligence but are not the methods used most frequently. In addition, although most companies seem to appreciate the need for regulatory intelligence as a strategic compass, much could be done to improve its effectiveness and efficiency, the author reports.
Reviewing nitrosamine contamination
The identification of nitrosamine impurities in some drug products has prompted manufacturers to recall the products over concerns about the carcinogenic properties of nitrosamines. Agencies and manufacturers are evaluating the risks and chemistry of the drug products to find a solution to the contamination. In Nitrosamine impurities: Regulatory action in the US, EU, and Canada, Alok Bandyopadhyay, PhD, RAC, reviews current information about nitrosamine impurities contaminations.

Upcoming in Regulatory Focus
What’s coming in May?
Articles during May will focus on the EU Medical Device Regulation and In Vitro Diagnostic Regulation. Look for this topic and more throughout May at Regulatory Focus.
And June?
For the June issue, Regulatory Focus will examine nutrition in health and disease management, and the gut microbiome.
Call for articles
July monthly issue
In July, Regulatory Focus will cover real-world evidence and data. The submission due date for articles is 16 June 2021. To contribute, email rmatthews@raps.org.
Upcoming in RF Quarterly
Regulatory Focus launched the inaugural issue of RF Quarterly in mid-March, and the second issue, focusing on artificial intelligence, will be available in June.
Each issue of RF Quarterly is comprised of original content, developed around a theme, as a member-exclusive benefit. The themes for the rest of 2021 will be:
  • Quality and Compliance in Regulatory Affairs (September)
  • RAPS 2021 Convergence (December)
To contribute to the September or December issues of RF Quarterly, email rmatthews@raps.org.
For more information, see Guidelines for Authors and the 2021 Editorial Calendar.


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