Essentials of High-Performing Regulatory Teams

Regulatory teams are unique in that they are structured with the express goals of getting medical products to market and leading them through lifecycle management activities, while ensuring the products remain in compliance with worldwide regulatory and legal requirements. These are lofty goals. To position regulatory teams for success, senior leadership must hire and retain talent with the right education, skills and experience. But qualifications alone are not enough; the individual team members must collaborate effectively to complete the tasks and achieve the goals.

Indeed, the success of a pharmaceutical, biologic or device company hinges on the regulatory team's ability to deliver on business goals and, for that reason, a high-performing team is a prized asset. Companies often invest in their employees through training and ongoing coaching to build and maintain high-performing teams.

This article explores some of the characteristics and challenges of regulatory teams that support the development of drug, device and biologic products (collectively referred to as "product"). Also, in companies that develop products, regulatory teams may be formed to create, implement or improve regulatory processes; therefore, many of the teamwork principles in this article are applicable to process-oriented teams.

Regulatory Team Membership

The membership of a regulatory team may differ depending on such factors as the size of the company, the stage of product development, whether the company has marketed products in one or more countries and whether it has partners or other third-party relationships (see Figure 1). Generally, small companies working on getting their first product to market adopt an "all-hands-on-board" approach, with everyone from the CEO to administrative personnel participating in regulatory team meetings to prepare for important interactions with health authorities. In larger companies, senior leadership is more hands-off; in such instances, the team is empowered to devise regulatory strategies and execute them with guidance from executives as needed. In larger companies, separate resources are available for regulatory functions such as regulatory writing and publishing, which in smaller companies may be outsourced or undertaken by team members who, by necessity, wear multiple hats; where such resources are available, they form an integral part of the regulatory team membership.

Teams can include external members representing partner or joint venture companies and vendor companies (such as contract research organizations, contract manufacturing organizations and providers that help prepare for advisory meetings). Further, in today's global economy, team members often are located in different countries.

Despite differences in membership, high-performing teams share common characteristics: first, a dynamic, high-impact team leader with a clear vision and the ability to articulate it, who charts the course and constantly steers the team to stay on course; and second, members who are collaborative, trustworthy and who hold themselves and fellow team members accountable for delivering on their commitments.

Team Member Strengths

High-performing regulatory teams, by definition, have been given a set of business goals and carry out activities that are narrowly focused on attaining those goals; they deliver superior results and outperform expectations. Team members connect personally with the team's vision and mission, understand their specific roles and grasp how their actions will contribute to the success of the team as a whole. They are committed, high-energy individuals who have a honed sense of accountability, are self-directed and feel empowered to do what is needed to meet their goals. Team members are highly knowledgeable about the science behind the product and the disease condition it targets for diagnosis, prevention or treatment, and they vigilantly stay abreast of competitive intelligence and the changing global regulatory landscape. Not only are they highly knowledgeable in their area of expertise, they also have the ability to think critically and strategize. They are straightforward, clear communicators. As part of the team, they are bound tightly together by their common purpose and are skilled and cross-trained adequately to redistribute workload when needed. This ensures the team's success is not dependent on any single individual whose unavailability could critically obstruct the team's goals.

Collectively, high-performing teams share norms, values and expectations that elicit elevated levels of tolerance, collaboration, innovation and mutual trust; these traits usually reflect a company's culture and are fostered by its senior leadership. New teams often have a written charter that spells out the desired norms and values, giving members a head start on developing these characteristics.

While they share core values, the members of a strong team are diverse in expertise, experience and viewpoints, enabling them to generate innovative ideas. Importantly, they are rewarded for creative solutions, which are especially appreciated when the challenges are complex. When mistakes are made, the team quickly learns from them and gets back on course.

A stark reality is that team membership changes as people leave the company or switch jobs. Each time there is a change, a strong team ensures new members are adequately onboarded. If the team's membership is altered significantly, the team may need to re-charter and collectively refocus on the business goals. Last but not least, a high-performing team strives to deliver high-quality outputs and has well-communicated risk mitigation strategies (see Figure 2).

Team Leaders

The team leader often is selected because the leader is able to deliver results and has inherent leadership qualities such as the ability to positively influence people, manage expectations and communicate clearly and to different audiences up and down the company's hierarchy, as well as with external stakeholders such as partner companies.

Team leaders have added responsibilities (see Figure 3) and thus require additional skills to carry them out. These include communicating the team's goals and how they fit in with the company's business goals, timelines and commitments made by the team to stakeholders.

The team leader must also have sound decision-making skills. To this end, the leader must empower team members to provide assenting as well as dissenting information to allow informed decisionmaking. In some teams, members are selected to play devil's advocate to ensure team members have thoughtfully worked out risk-mitigation options. While team members are responsible for the decisions, accountability for the team decisions, despite a participative decision-making process, remains with the team leader (who in turn, must ensure that the company's leadership team is in agreement with strategic team decisions). The team leader is also tasked with establishing and communicating methods to resolve conflicts promptly and with the required degree of transparency so that the team can quickly get back to the job at hand.

Globalized Teams

Today's regulatory team membership is increasingly global. In the case of a product marketed in several countries, local regulatory employees or third-party agents may represent these countries on the team. In such cases, the team must overcome additional challenges. For instance, the members may take a little longer to bond and develop relationships, collaborative skills and mutual trust because they are not working together face-to-face everyday. Routine teleconferences are absolutely essential for such teams and it is very helpful to hold video conferences at least monthly so team members can get to know one another's facial mannerisms, body language and differences in cultural norms, practices, expressions and humor. Budget permitting, the members should try to convene once or twice a year to work on team-building exercises and strengthen relationships. In any case, the team leader has the added responsibility of ensuring remote team members are onboarded and up to speed so they can contribute sooner rather than later toward the goals and deliverables. The timing for routine team meetings necessarily is limited by different time zones. In situations where urgent and ad hoc meetings are necessary, team members have to be flexible and take such meetings outside business hours. Rarely, urgent face-to-face interactions with a health authority may be necessary and a critical team member may not be able to attend in person; it is prudent to plan fallback positions for such situations.

Conclusion

Finally, a team that consistently performs at a high level continually assesses its performance and effectiveness with the goal of continuous improvement. To assess team performance, the team leader can seek informal feedback at least twice a year from stakeholders and customers, as well as from team members and line management. The team leader should then synthesize the responses and review both positive feedback and areas identified for improvement with the team.

A more formal assessment of the team's performance should be conducted by the company's leadership at the end of each year through formal 360^o feedback from team members themselves (including the team leader), the team's customers and stakeholders, and team members' line management. Such feedback will provide valuable input on practices that worked and those that did not work. The leader must help members learn to evaluate this feedback objectively, adapt to the guidance provided and implement lessons learned into their goals for the following year. Collectively, the team should revisit these commitments throughout the year to ensure they remain on track.

A high-performing team that becomes stagnant will quickly become a mediocre team or, worse, fall below expectations. Staying on top of the game requires dynamic leadership and ongoing effort by each member.

About the Author

Naseem Kabir, MS, RAC, is director of regulatory affairs at Amgen Inc. She has more than 18 years of hands-on experience in various capacities, including as a team leader for global regulatory teams. Kabir is also a member of the Board of Editors for RAPS' Regulatory Focus. She can be reached at [email protected].

The views expressed herein represent those of the author and do not necessarily represent the views or practices of the author's employer or any other party.

Cite as: Kabir N. "High-Performing Regulatory Teams." Regulatory Focus. March 2014. Regulatory Affairs Professionals Society.