Regulatory specialist, generalist, or generalized specialist: Weighing the options

Feature ArticlesFeature Articles | 30 April 2022 | Citation

This article explores the role of a generalist and a specialist within the regulatory profession, as well as considerations in today's evolving regulatory landscape. To decide on the best path forward, it is important to understand current global market expectations from the regulatory profession, as well as compensation depending on job level and education in the healthcare sector.
 
Keywords – generalist, generalized specialist, professional development, skill sets, specialist
 
Introduction
There is much debate over the merits of building a generalist versus specialist skills set from the regulatory professionals’ perspective. Generalists and specialists are two broad functional categories seen in many organizations. The roles are based on the way an individual operates and develops within an organization. Both roles play a significant part in the company’s growth and goals, as well as the regulatory team’s development. Many regulatory professionals starting out in their careers will weigh which pathway they should consider. Some might already be well into their career in one of the pathways when they begin wondering if they made the right choice. Choosing a specialist or a generalist pathway is not an easy decision, primarily because of the continuously changing global regulatory landscape and the fact that most RA careers fall somewhere in between the generalist and specialist options.
 
The regulatory profession
The regulatory profession encompasses multiple levels, ranging from entry-level professionals to highly experienced professionals with extensive technical knowledge and management responsibilities. There is greater awareness today of the critical role played by regulatory professionals as they face a world that is notably different from 10 years ago. There are new emerging technologies, such as artificial intelligence and machine learning (AI-ML), at-home virus detection kits, wearable patient monitoring devices, and improved patient engagement within a truly global marketplace. As innovation occurs, and regulations are revised or created anew, regulatory professionals must stay relevant and have the necessary skills and competencies to make meaningful contributions to their organizations. Those who can successfully navigate this dynamic landscape remain in high demand – and short supply.1
 
Regulatory professionals working for healthcare companies affect nearly all phases of a healthcare product's lifecycle as part of their work to gain and maintain regulatory approval (Figure 12). Although they share the common goal of ensuring product safety through regulatory compliance, there are notable variations in the scope and responsibility of a regulatory professional's work, depending on company size, product portfolio, development timeline, professional career levels, and organization.
  
Figure 1. RA profession: Integral to the healthcare product lifecycle2
 
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RA workforce statistics
RA professionals are often employed by medical device, pharmaceutical, biotechnology, contract research organizations (CROs), and academic institutions. According to a recent joint report global regulatory workforce,3 nearly 100,000 professionals globally currently work regulatory affairs (RA) for healthcare products. The profession tends to be largest in the pharmaceutical category, which represents about 65% of all regulatory professionals. About 24% of professionals in the field work in medical devices and the remaining group, at just under 11%, are employed in biotechnology (Figure 2).3
 
Figure 2. Global regulatory professionals by sector3
 
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Generalist vs specialist career pathway
When building a career in the RA profession, one should consider one’s career end goal and understand that the rules and regulations surrounding healthcare are constantly evolving. That means regulatory professionals may require professional development on a regular basis to hone necessary skills, knowledge, and qualities to stay up to date and demonstrate expertise. To decide which career path (generalist vs specialist) is more valuable, it is helpful to understand the roles of generalists and specialists in a real-world regulatory professional setting.
 
Generalist, or dash-shaped, career path
Generalists are the competent “jacks of all trades,” that is, they understand a wide range of topics within the regulatory setting (Figure 34). Their knowledge range could be labeled “horizontal,” that is, they are experienced in many areas of regulatory affairs, but do not have an in-depth knowledge base. Generalists understand all the moving parts of the role and work well collaborating between departments. They can see the big picture and think out of the box.
 
Figure 3. Generalist (dash-shaped) professional4
 
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 Typically, regulatory professionals working in a small healthcare company work as generalists, mainly because there a few employees in each department. Small companies often have a small team with multiple responsibilities. As a result, RA professionals are involved in more than one aspect of the business, such as regulatory affairs, compliance, clinical, and/or quality assurance. Because of their experience in a range of areas, RA professionals in a small company are an ideal conduit in larger teams to develop complex regulatory strategies.
 
Regulatory professionals, who may have jobs such as regulatory coordinator, study coordinator, regulatory associates, regulatory affairs specialist (RAS), or senior RAS in small or large companies can be considered generalists. These professionals are typically involved in various activities, such as information management, document preparation, file maintenance, project tracking, labeling review, data review or general support for the submission work. As their careers progress, they help with tasks such as reviewing product promotional materials, labeling, manufacturing changes for compliance with applicable regulations and policies, as well as supporting the renewal of licenses and regulatory submissions. The general focus is on developing general knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, processes, and procedures.
 
There is a saying that the jack of all trades is a master of none. Generalists, for the most, are not specialized or have a high level of expertise in any one area. They have a more diverse knowledge base that allows them to see connections and correlations that specialists might overlook. Because generalists have a lesser knowledge of a broad range of topics, they must continue to work on developing more advanced and valuable skills. For instance, someone who has worked on Class I/II products, might want to gain experience with Class III products, and someone who supports US and/or the European Union might want to broaden their knowledge base by learning about international regulatory processes and regulations. Alternately, someone who prefers to stay focused in one geography might not want to limit their entire career to only one area, such as postmarket activities, but might also want to get exposure of premarket activities, including developing regulatory and clinical strategies, interacting with regulatory agencies, supporting audits and/or compliance activities, and authoring submissions. Once one begins to acquire additional technical and soft skills, one may develop into an “expert generalist,” which is more distinct and more difficult to replace in the regulatory environment.
 
Pros of being a generalist
  • Adaptability and career flexibility – Generalists often possess transferable skills, allowing them to be flexible with their career choices and adapt to a changing landscape. If someone is working in clinical research, their clinical expertise, communication, organization teamwork, and conflict resolution capabilities may be their most transferable skills when it comes to crossing over to verticals such as RA.5
  • Cross-functional department connections – Generalists have strong cross-functional connections as they work on many aspects within a company. Having a wide knowledge base helps to build connections between departments and find solutions to an array of issues that a specialist may not be able to accomplish. 5
 
Cons of being a generalist
  • Exhaustion – Generalist may be required to perform multiple responsibilities across different teams. This may lead to overburdening and eventual burnout at a some point their careers.5 
 
Specialist, or I-shaped, career path
“I-shaped” regulatory professionals are specialists (Figure 4) – they are the experts in a specific field. A specialist is a person whose knowledge coverage is "vertical," that is, they are not necessarily familiar with all aspects of regulatory affairs, but instead, are more narrowly focused, with a deep knowledge and experience in a specific area.6
 
Figure 4. Specialist (I-shaped) professional6

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Regulatory professionals working in large corporations may typically be involved with more specialized work because there are more staff. Most small companies do not hire specialists, mainly because of budget limitations. Regulatory professionals are considered specialists if they have mastered some key fundamental technical competencies and would include RAS, senior RAS, and principal RAS; chemistry, manufacturing and control RA specialists; regulatory advertising and promotion specialists; labeling specialist; RA fellow; and distinguished RA adviser.
 
These specialists may be intricately involved in product development, clinical trials, manufacturing practices, and submission processes. They often advise project teams on subjects such as pre- and postmarket regulatory requirements, export and labeling requirements, advertising and promotion regulations, and clinical evidence strategies where cross-functional, risk-based decision making is critical. Regulatory specialists are expected to have a thorough understanding of the regulatory landscape to ensure compliance by providing strategic regulatory guidance throughout the drug/device product lifecycle. Regulatory specialists act as a liaison between business and government agencies, shepherding medical products from inception to market.7,8
 
Because the regulatory landscape is continuously changing, it is essential to be able to embrace change, continue to learn, and promote awareness for these changes. To have a successful career, regulatory specialists need to continue adding depth of knowledge to complement their knowledge base. In addition, it is important at this level to hone one’s communication skills, which include aspects of both technical and soft skills. It is critical to be able to succinctly express and support key messaging, whether authoring a submission (e.g., investigational device exemption, 510(k), or De Novo), responding to government inquiries, or creating slides for internal and/or external presentation.
 
Once a regulatory professional has demonstrated an advanced knowledge of RA in one region, it is increasingly important to expand the geographic knowledge or “footprint.” For example, a professional who has been supporting the US region for a Class III medical device, should consider learning about Class III product development pathways in other regions, such as the EU, Japan, or Canada.8
 
Regulatory professionals who attain the role of RA Fellow or Distinguished RA Adviser are considered to be regulatory subject matter experts (SME). These positions represent the pinnacle of a specialist career path.
 
Pros of being a specialist
  • Better compensation and less competition – Specialists are considered experts in their field. Specialists benefit greatly when their abilities are in high demand. The scarcity of their expertise means higher compensation and less competition.5
  • Domain expertise and transferable skills – Specialists have the opportunity to become a true thought leader in their area of expertise. They are likely the “go-to” expert in any organization in their field of work. Some of the most transferable skills include domain expertise, meticulous attention to detail, strong oral and written communication skills, and analytic and strategic thinking.
 
Cons of being a specialist
  • Career inflexibility – Specialists have very specific skills and knowledge. Finding positions outside of their area of expertise can be difficult at times. Specialists continue to focus on fewer areas, which allows them to expand their knowledge base. A specialist who has demonstrated advanced knowledge of RA in one geography, might consider learning more about the general considerations necessary for developing a comprehensive regulatory development plan.5
 
Oppenheimer_gen-vs-spec_Table.png
 
On the one hand, one could argue that specialists are in more demand because of their expert knowledge of a specific platform. On the other hand, one could argue there is more demand for generalists because of their transferable skills and adaptability, which allow them to easily transition to new roles and projects. The fallacy of this statement is that one cannot compare demand for generalists with demand for specialists because no one person can be a specialist of everything. The key is to recognize that one must continue to develop the skills of the other type to be successful. The abilities for specialists to broaden their skillset and generalists to deepen their knowledge in a select few competencies are what distinguishes them from the average regulatory professional. Those opting for this path are referred to as generalized specialist or T-shaped professionals.
 
Generalized specialist, or T-shaped, career path
Generalized specialists are “T-shaped” individuals with a depth and breadth of expertise (Figure 5). T-shaped professionals  are deemed as being the best of both worlds.9  The horizontal stroke of the T represents the breadth of understanding, and the vertical stroke represents deep understanding in one narrow area. T-shaped professionals are being called upon to play a critical role in complex problem-solving.9,10
 

Figure 5. Generalized specialist (T-shaped) professional

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When moving to a leadership position, RA professionals integrate regulatory knowledge throughout the product lifecycle with aspects of effective management and strategy development. Regulatory professionals at this level hold positions such as director, executive director, vice president, and chief regulatory officer.
 
This level represents the move from the technical and tactical dimensions of RA and the product lifecycle into a more strategic role. Professionals at this level have strong technical and management skills and are actively engaged in regulatory strategy and operations. These professionals are also involved in business and organizational activities, and strategy in policy development within their organizations and external groups. They typically are leaders and mentors within their organization and for the profession.

 
Comparing generalized specialists, generalists, and specialists
Briefly, a generalist has roughly the same depth of knowledge of multiple areas, whereas a specialist is narrowly focused on fewer skills. A generalized specialist has a focused area of expertise and in addition, has a wider breadth of experience with other skills, such as business acumen, greater interconnectivity with cross-functional groups, open and better communication skills, strong shared vision of business goals, collaboration, and creative innovation.9 Furthermore, both I- and T-shaped professionals are essential in any organization; one is not better than the other, though it is worth considering developing both sets of skills.9
 
Deciding on a career pathway
Building a career in RA requires a combination of soft skills, such as communication expertise, and "technical" or hard skills, such as in-depth knowledge of drug/device/biologic development and related regulations and processes. There is no right or wrong answer when it comes to deciding whether to be a generalist, specialist, or generalized specialist because there are too many variables to consider. Small companies may need more generalists, whereas larger companies may require both generalists and specialists. A company developing a breakthrough technology may need a specialist with deep expertise in a certain field such as AI/ML, software, or drug-device combination products. Companies, on the whole, require both generalists and specialists who can assist with a variety of regulatory responsibilities. On average, most regulatory careers fall somewhere between generalist and specialist. Whether one starts one’s career as a generalist or a specialist, one may, over time, learn to be a generalized specialist who is skilled in one area but willing to learn other areas.
 
The ideal path for an individual cannot be defined by any single method. The generalist-to-specialist-to-generalized specialist or specialist-to-generalist-to generalized specialist approaches may outline successful career paths. It is important for one to focus on what is meaningful, will help advance one’s career, and above all, what interests one. Pursuing a career path based on one’s interests can lead to personal satisfaction as well as professional success. Figure 6 maps the process for planning one’s career, beginning with an assessment of one’s professional strengths and weaknesses.
 
Figure 6. Regulatory career development planning process
 Oppenheimer_gen-vs-spec_Figure-6.png
 
Based on one’s strengths and core values, the next step would be to consider:
  • Personal strength areas. Some people are extremely detail-oriented and able to focus on specific tasks or activities, with unmatched commitment. They also have a strong desire to learn most everything there is to learn about any topic that catches their interest, so they dig deep for information. Their learning style is more vertical or depth oriented. A career as a specialist could be a great fit.
 
On the other hand, some people work better when they get a variety of tasks to do. They want to be exposed to multiple activities and a variety of flavors, rather than spending too much time on a single activity. Their learning style is more broad-based and horizontally distributed. Those individuals may find success by choosing a generalist career path.
  • Career aspirations and goals. One’s career aspirations and goals play a significant role in the path one choses. If one’s professional ambitions align toward gaining knowledge of various areas, then the generalist path may be a good fit. If being an expert is important, then pursuing a specialist role leading to an RA fellow or distinguished RA adviser role is the way to go. If the goal is to become a functional leader who wears multiple hats, then a T-level or generalized specialist career path would be the best choice.
  • Motivation. It is usually the inherent motivators, such as a competitive salary, being empowered, learning new things, or having stability that motivate professionals to give best to the job. Career planning is a continuous process; if one is motivated, one is on the right career path. 
  • Compensation. Many people decide their career path based on compensation. The salary for the same role may vary from one organization to the next. Most successful regulatory professionals tend to blend specialized skills (I-shaped) with generalized skills (dash-shaped) to get the best of both worlds (T-shaped).
 
Conclusion
In general, a person’s career is the result of a series of personal decisions and experiences. Choosing between generalist and specialist is not a one-and-done decision. Career planning and changes in direction can occur throughout a person’s working lifetime. Many times, regulatory professionals do not decide on the specialist or generalist path right from the beginning. They take the opportunities as they come their way, exploring both routes before deciding on a preferred career path.
 
If one is new to RA, one should focus on one’s personal strengths, motivation, interests, and career aspirations in deciding which path to choose. For those who are already working in regulatory, initial work experience and job satisfaction in previous roles should help in figuring out what course to pursue. Professionals who feel stagnant in their careers are likely generalists at a company that requires specialists, or vice versa.
 
If one is curious about a new direction, one should be brave and pursue one’s interests, no matter where one is in one’s career – the goal is always to master the tools needed for one’s career journey.
 
About the authors
Rupali Gupta, MS, is a senior principal regulatory affairs specialist at the US Regulatory Diabetes Group at Medtronic. She is a seasoned regulatory professional with more than a decade of experience in the medical device and pharmaceutical industries. The focus of her career has been developing and executing global regulatory strategies for a range of medical devices, enabling products to reach target markets in the shortest possible time to drive business growth. She has extensive experience working with coronary, peripheral, diabetes, and digital health medical devices. Rupali has also been involved in acquisitions and integrations. Gupta holds a master's degree in regulatory affairs from St. Cloud State University, Minnesota, and a master's degree in microbiology from Gurukul University, India. She can be reached at rupali.gupta@medtronic.com
 
George Cusatis, MS, RAC, is senior manager of regulatory affairs at the US Regulatory Diabetes Group at Medtronic. He joined the company in 2021 with more than 20 years of scientific experience in research and development, clinical development, pharmacovigilance, quality assurance, and regulatory affairs within academia, food, pharmaceutical, and medical device industries. He belongs to several industry trade organizations, where he has more than 35 recognized certifications, has 40-plus publications and speaking engagements, and has chaired several conferences. Cusatis has a master’s degree in regulatory affairs and quality assurance (Temple University), a master’s degree in bioengineering (Syracuse University), and a bachelor’s degree in biology from Wilkes University. He can be reached at george.a.cusatis@medtronic.com
 
Darin Oppenheimer, DRSc, FRAPS, RAC, PMP, is senior director of regulatory affairs at the US Regulatory Diabetes Group at Medtronic. He has 19 years’ experience in many facets of the product development lifecycle, including regulatory submissions and due diligence. He has actively participated with industry trade organizations and on standards committees. Oppenheimer’s time as a research and development scientist focuses on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. He has an undergraduate degree in molecular biology from the University of Tampa; two masters’ degrees from Johns Hopkins University, in biotechnology and regulatory science; and a graduate certificate in biotechnology enterprise, also from Johns Hopkins. Oppenheimer completed his doctorate degree in regulatory science from the University of Southern California and is a 2017 Regulatory Affairs Professional Society Fellow. He can be reached at darin.s.oppenheimer@medtronic.com
 
Disclaimer The opinions expressed in this article are solely the authors’ and do not express the views or opinions of Medtronic.
 

Citation Gupta R, Cusatis G, Oppenheimer D. Specialist, generalist, or generalized specialist: Weighing the options. Regulatory Focus. Published online 30 April 2022. https://bit.ly/3KwIf5C


References
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