Complex Relationship

The evolving role of the regulatory professional

by Les Schnoll

As organizations regulated by the U.S. Food and Drug Administration have grown and the desire to market their products globally has increased, it is critical for regulatory professionals to keep up with that demand.

You may think this is a relatively simple process, but the constraints and roadblocks set by organizations make it more difficult than it needs to be.

In addition to being required to master a multitude of global requirements, regulatory professionals must address other issues that impede their ability to function expeditiously, including:

  • Getting caught between a rock and a hard place—the organization vs. the regulatory body.
  • Not knowing the line between conformance and nonconformance.
  • Being perceived as a roadblock or impediment to progress.
  • Lacking broad knowledge of management.
  • Working in a role atypical of the core executive strategic pathway.
  • Being unable to deal comfortably with gray areas.
  • Fighting the perception that their decisions are made in a regulatory vacuum.
  • Working for organizations that don’t speak the language of regulators.
  • Being accused of divided loyalties—the organization vs. the regulatory body.
  • Having low visibility.
  • Having difficulty managing expectations.
  • Needing to constantly legitimize their role.
  • Suffering from professional identity crisis.
  • Fighting the perception their role is not a value-add.
  • Being accused of regulatory "decision shopping."
  • Dealing with an increasingly global business environment, multiple regulatory agencies and external forces, such as trade associations, litigators and customers.
  • Not being perceived as a strategic business partner.

How can a regulatory professional address these issues while best serving all stakeholders? For starters, they need to assess the current situation and determine what can be changed, including:

  • Their communication with the organization (not speaking only the language of regulations).
  • Personal relationships and alliances.
  • Their understanding of the organization.
  • How they manage conflict resolution.
  • Their visibility and credibility.
  • Their mission statement and vision.
  • How they develop and share their values and beliefs.
  • The organization also needs to provide assistance to regulatory professionals by changing and improving:
  • Leadership’s perception of the role of regulatory professionals.
  • How other employees are informed and educated about the role.
  • The recruiting process.
  • The amount of participation on teams within the organization.

Phase shift

As shown in Figure 1, there are five distinct phases in the relationship between organizations and regulatory professionals, and each phase has its own impact on regulatory compliance.

Figure 1

In the dissociative phase, the organization’s objectives are minimal intrusion when it comes to operations, minimal compliance effort, comprehensive quality inspection, minimal training costs and the implementation of superficial processes.

In this environment, the regulatory professional’s role has little or no involvement in regulatory issues, protecting the organization from enforcement activities, using outside counsel when required and minimizing costs.

Needless to say, these are not the hallmarks of a healthy relationship, and the potential consequences of operating under this scenario can be disastrous.

In the reactive phase, the organization’s objectives include achieving basic compliance, implementing rudimentary quality assurance or quality control functions, avoiding serious violations, minimizing costs, implementing basic design controls, meeting basic reporting requirements and accepting product classification risks.

The regulatory professional’s role in this phase involves enforcement, identifying areas of significant noncompliance, minimizing enforcement costs, responding to inspection findings, managing inspections with no defined process and defending the organization when violations occur.

The reactive phase is slightly better than the dissociative stage, but not by much. The name says it all: Being reactive is in no one’s best interest.

The proactive stage provides the first indication the relationship between the organization and the regulatory professional is reaching solid ground.

The organization’s objectives are to perform gap analysis, involve senior management, implement an effective regulatory and quality program, audit for compliance, conduct training, communicate with regulatory agencies, solicit employee input and demonstrate a cost-benefit advantage.

The pressures on regulatory professionals begin to be alleviated, and they can accomplish what they were hired to do. The role now involves understanding regulatory requirements, anticipating regulatory changes, recognizing regulatory issues in other business processes, advising and training, protecting the organization’s interests during regulatory inspections and keeping management informed.

Getting closer

The interactive phase is the fourth step in the journey. At this stage, the organization’s objectives include:

  • Setting quality and regulatory objectives with senior management.
  • Involving design, manufacturing and procurement teams early in the regulatory process.
  • Communicating constantly.
  • Exceeding regulatory agency compliance standards.
  • Achieving continuous improvement.
  • Anticipating change.
  • Focusing on prevention.

In this phase, the regulatory professional’s role is to be proactively involved with the organization, to understand the organization’s strategies and goals, to secure early involvement from all levels within the organization, to agree on expectations for timeliness and quality of output, and to develop a compliance and prevention strategy.

The summit is the synergistic phase. When the organization reaches this level, its objectives include ensuring:

  • Quality is internalized at all levels.
  • The regulatory department is aligned with corporate strategies.
  • Regulatory and quality considerations are the top priority in mergers and acquisitions.
  • Prevention eliminates the need for quality control inspections.
  • Management views regulatory agencies as customers.
  • Root causes of problems are identified and eliminated.

At this point, regulatory professionals can breathe a sigh of relief because their role now involves strategic alignment, trust-based relationships, early participation in new product development and mergers and acquisitions, contracting with the organization for performance metrics, and developing and communicating a risk or opportunity profile. Now, compliance is viewed as a value-added activity by the organization.

Hard road

Regulatory professionals don’t have an easy job. Initially faced with constraints and roadblocks put in place by organizations, it is almost impossible to perform the job expected by all stakeholders, including regulatory agencies.

As the regulatory environment evolves within the organization, the role becomes more palatable, and activities can be accomplished more easily. But true progress can’t be made until the relationship reaches the interactive and synergistic phases.

Make sure you assess the status of the organization and determine where it stands in the evolutionary pyramid. If it’s not in the interactive or synergistic phase, a plan should be put in place to help move the organization in the right direction.

Les Schnoll is principal of Quality Docs LLC, which provides quality and regulatory consulting services to industries regulated by the U.S. Food and Drug Administration. He earned a doctorate in health law from Concord University School of Law in Los Angeles. He is a senior member of ASQ and an ASQ-certified quality engineer, auditor and manager. A member of the U.S. technical advisory group to ISO 9000 technical committee 176, Schnoll wrote The Regulatory Compliance Almanac.

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