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Strengthening the regulatory profession through resilience and diversity

Posted 30 September 2021 | By Phyllis Marquitz, MS, JD  | ©

Strengthening the regulatory profession through resilience and diversity

This article explores the importance of resilience and diversity specific to the regulatory profession in preventing burnout and enhancing overall regulatory capability within an organization. The author addresses existing tools for  functional capability-building and supplemental considerations when intentionally building resilience into regulatory functions.
 
Introduction
Regulatory affairs, or in many cases, a combined functional department named “regulatory and scientific affairs,” performs a critical role in product compliance, approval/product permissibility, and contributes to the strategic growth agenda for product and ingredient companies.
 
Regulatory professionals deliver input for decision-making that characterizes risk and readiness for product development and launch stages. Those assessments and recommendations affect timelines and significant commercial outcomes. The nature of work requiring translational regulatory science, innovation feedback, risk assessment and management, and product marketing review, inherently crosses tension points within a company. An additional element is the dynamic external regulatory environment. Such tensions can lend themselves to burnout in individuals performing these crucial tasks.
 
Much has been written and researched around the definition of burnout in the workplace, along with personal and organizational remediation and coping mechanisms. There have also been carefully developed tools for building competency for regulatory affairs. These subjects intersect where resilience is intentionally pursued, and resilience is strengthened through diversity.
 
Defining burnout in the workplace
In 2019 the World Health Organization (WHO) included burnout in its classification of diseases, defining it as a “workplace phenomena” that has been characterized by chronic workplace stress resulting in feelings of energy depletion or exhaustion, increased mental distance from one’s job or feelings of negativism or cynicism related to one’s job, and reduced professional efficacy in an occupational context.1 Subsequent research conducted by Gallop2 measured main causes of burnout tied to work to be:
  • Unfair treatment at work,
  • Unmanageable workload,
  • Lack of role clarity,
  • Lack of communication and support from managers, and
  • Unreasonable time pressure.
 
The leading focus on work-life coping mechanisms has been on leveraging aspects of self-care, such as mindfulness, sleep, healthy lifestyle choices. Although those tools remain linked to positive practices, they focus on individual coping and mitigation when it is clear that the WHO definition and subsequent data point to workplace strategies as preventative practice.3  The ideal is to create structure and culture that prevent workplace burnout in the first place.
 
Regulatory critical competencies and burnout
The nature of work delivering input for decision-making that characterizes risk and readiness for product development and launch stages can be perceived by counterparts as restrictive and limiting. In many companies, the root of this perception is driven by a lack of understanding of cross-functional purpose and priority. This can lead to insular mindsets that blind other departments’ contribution and slowly decline into siloed working.4 Translation of science into the regulatory framework requires communication that can put a strain between innovation and regulatory science, particularly when the weight of the data does not reach the regulatory standards for measurement of efficacy or claims substantiation. Regulatory professionals spend their careers identifying issues that have reputational and legal consequences if not addressed. Those assessments and recommendations, even when delivered through careful communication, affect delivery timelines and commercial forecasting. Internal stakeholders can become frustrated with this dynamic and push back against assessments or decisions, and these tension points are ripe for breakdowns in communication and a buildup of pressure.
 
Regulatory professional organizations have created competency models that capture development frameworks, step-by-step role progression, and crucial skill sets that thoroughly consider the tangible focus on learning regulatory systems, product and reporting requirements, legislation, and processes as applied to agnostic to product categories. These frameworks build from foundational skills that require knowledge of science or engineering, laws and regulations, market environments, enforcement, and products. They then build toward strategic engagement skills cross-functionally within the company, as well as externally with competent authorities.
 
In the 2019 update of the Regulatory Competency Framework (RCF) from the Regulatory Affairs Professionals Society (RAPS), a tool has been developed specifically for addressing behavioral indicators5 and to further build on competencies, such as ethics, leadership, business acumen, and communication, and address development of standard operating procedures (SOPs).6 The framework was updated following a survey by the society to better understand how the RCF was being used. When respondents were asked why they did not fully apply the model, they said the model lacked “real-world applicability.”2 Considering the nature of regulatory work, and the dynamics that persist within companies, the expansion of the competency tools was a logical approach to building in mechanisms that make the regulatory models more resilient.
 
Another factor in regulatory burnout is the connectivity between regulatory input and processes owned by other functions. Developing SOPs within regulatory affairs can provide clarity and expectation for turn-around time and functional key performance indicators, but often regulatory department inputs are part of SOPs or processes that are owned by others. If there is tension around collaboration or those processes do not account for regulatory issues, frustrations often get pushed back onto the function. This can impact perceived respect or fairness, unreasonable time pressures, and other conflict in line with burnout.
 
Organizational resilience and diversity
Organizational resilience can be defined as the ability to anticipate potential threats, to cope effectively with unexpected events, and to learn from those events to produce a dynamic capability that is directed toward facilitating organizational change. 7 That definition summarizes the importance of the regulatory function in delivering organizational resilience. However, it also can be turned back toward the profession itself in addressing cross-functional dynamics and the preparedness for conflict within a company.
 
The RAPS RCF is designed to be agnostic to category, but it generally applies to areas in which RAPS can certify knowledge of frameworks for pre-approved products and frequently references health care (pharma, biologics, medical devices). However, the competency framework is designed to be universal and useful in sectors that have more ambiguous premarket decision-making. Sectors such as food, ingredient, and dietary supplements have more flexibility for internal decision-making with regard to launch and marketing.  There may be variations in internal process dynamics and SOPs from company to company, often built around the production and development processes of the product itself or the target market. Distribution and other commercial considerations can also impact internal regulatory review and risk determination processes. By applying the lens of resilience and setting resilience as one of the desired outcomes, the RCF promotes good communication, accountability, ethics, and further details openness to diverse ideas, opinions, and insights.
 
Diversity is a broad term that is often applied to categories such as gender, nationality, ethnicity, culture, religion, worldview, disability, age, sexual orientation, and identity.8 Individuals who bring variety from these dimensions contribute to resilience by offering a broader knowledge base.7 It is particularly important to have variety in the three process stages of organizational resilience:
 
  • Anticipation. For anticipation, diversity is helpful for observation and identification of risk.7 This is critical to the function of regulatory affairs, but also in anticipating tension points within the company and with partners with different priorities and objectives. Diversity also improves an organization’s ability to prepare for incidents and challenges.7
  • Coping. For coping capabilities, diversity contributes to a collective sensemaking and problem-solving approach.
  • Adaptation. Reflections and learnings are shown to be enhanced by diverse knowledge and experiences, and those foster robust adaptation ability.7
 
Personal resilience and diversity culture
Workplaces that emphasize diversity as a central, enduring, and distinctive organizational attribute are associated with openness, not only toward others but toward error and change within organizations.9 Openness and communication are also seen as important factors in shaping resilience of an organization because individuals feel valued for their contributions. Employees in a diverse environment where there is trust, help achieve shared situational awareness and better interpretation and assessment of critical situations.7
 
Gallup’s most recent State of the American Workplace report finds that only 60% of workers strongly agree that they know what is expected of them at work.10 Personal accountability and expectations are important for security and context of an individual’s role in the workplace. It is an area in which the RCF can provide a framework and when applied with more specific responsibilities, performance and development goals can provide regulatory professionals with confidence to deliver against their objectives. In the Galllup findings, employees who strongly agreed that they felt supported by their manager were about 70% less likely to experience regular burnout.
 
While organizational resilience with intentional diversity management is important, regulatory professionals can also draw on personal tactics, such as mental training practices associated with mindfulness. In dynamic work environments, organizational psychologists Erik Dane and Bradley Brummel found that mindfulness facilitates job performance. Intentional mental training practices, including deliberate time dedicated to focus, can predict judgment accuracy and insight-related problem solving.11 Compartmentalizing work and creating deliberate delineation of work activities, such as email or strategy and brainstorming, can be useful coping mechanisms for effectively processing and decreasing cognitive load and strain. 11
 
One of the most overlooked aspects of resilience, and one directly related to diversity, is cultivating compassion both self-compassion and compassion for others.12 Compassion, understanding, and business effectiveness are not mutually exclusive. Regulatory professionals can seek out resilience and diversity training as part of their personal career development goals and tie that investment back into the organization’s resilience.
 
Conclusion
Building resilience into organizational design through diversity can generate greater value for the organization and the health of the profession. Deliberate partnership and trust toward this end begins at the personal and functional level employing models that foster clarity about roles and accountability, communication, competencies, and critical skill sets with the express purpose of creating a resilient regulatory community.
 
From there, collaboration outside of the regulatory function can then drive value for the company and its customers. A simple model to test this interface involves three suggested rules:
  • Enhance understanding cross-functionally, jobs, and priorities,
  • Agree and deliver an achievable collaborative approach; and
  • Benchmark the impact of that collaboration against the overall success of the company.4
 
This will test the resilience and compassion built up first within the regulatory community and hopefully bring more diverse perspectives back in to inform the function in a positive cycle.
 
About the author
Phyllis Marquitz, MS, JD, is vice president of global regulatory & scientific affairs at Archer Daniels Midland (ADM), where she has overall strategic responsibility for regulatory affairs, regulatory science, product compliance, and policy matters across all ADM business units globally. She has more than 18 years’ experience in the food and agriculture sectors, working within academia, the US Food and Drug Administration, and consumer packaged goods. Marquitz has specialized expertise in horizon scanning and regulatory harmonization, including working with international organizations such as Codex Alimentarius, APEC SCSC, and is passionate about transparency and good regulatory practice in the development of nutrition and food safety policy. She holds a law degree from The Pennsylvania State University Dickinson School of Law, with a certificate in international, foreign, and comparative law, and a master of science degree in nutrition from James Madison University. She can be contacted at pjmarquitz@gmail.com
 
Citation Marquitz P. Strengthening the regulatory profession and professionals through resilience and diversity. https://bit.ly/3apqAxg. Regulatory Focus. Published online 30 September 2021.

References
References accessed 28 September 2021.
 
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  8. Triandis HC. The future of workforce diversity in international organizations: A commentary. https://iaap-journals.onlinelibrary.wiley.com/doi/epdf/10.1111/1464-0597.00146. Applied Psychology. Published 3 June 2003.
  9. Groggins A, Ryan A. Embracing uniqueness: The underpinnings of a positive climate for diversity. https://bpspsychub.onlinelibrary.wiley.com/doi/10.1111/joop.12008. J Occup Organ Psycho. Published 1 March 2013.
  10. Gallup. State of the American workplace [report]. https://www.gallup.com/workplace/238085/state-american-workplace-report-2017.aspx?thank-you-report-form=1. 2017.
  11. Fernandez R. Emotional intelligence: 5 ways to boost your resilience at work. Harvard Business Review. https://hbr.org/2016/06/627-building-resilience-ic-5-ways-to-build-your-personal-resilience-at-work. Published 27 June 2016.
  12. Suttie J. Compassion across cubicles: A new research movement tries to keep people from tuning out their emotions when they punch in to work. https://greatergood.berkeley.edu/article/item/compassion_across_cubicles. Greater Good Magazine. 1 March 2006.
 

 

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