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Regulatory Affairs Assessment

Introduction

The regulatory assessment is designed to answer the question of how are we doing? Is the department contributing to the company achieving its objectives? The assessment will help you to identify what the department is doing well and in what areas improvement is required. It is the first step in helping you to build a sound regulatory strategy.

"I was quite pleased to learn of the value associated with, and respect for, my group's expertise that was identified through the survey. It was also very gratifying to see the consistency of response between regulatory and non-regulatory staff who completed the survey."

-- Sr. Vice President, Regulatory Affairs

What is the Regulatory Assessment?

The Regulatory Assessment Survey is a thirty-six item questionnaire, divided into the five dimensions crucial to measuring the success of regulatory departments. The survey measures departmental effectiveness as seen by other departments within the company. The dimensions follow:

• Agency Interactions - How the department interacts with regulatory agencies.
• Team Relationships - How well Regulatory staff interact with the team and its members.
• Trust and Boundary Role Management- The degree to which the department and its members are seen as trustworthy and dependable.
• Problem Solving - The department's willingness to consider various options, as well as its overall problem-solving effectiveness.
• Organizational Responsibilities - How the department's interactions with senior management and the affiliates is viewed.

In addition to the direct questions, there are four open-ended questions that allow respondents the space to elaborate on their answers. The survey is scored on a five point scale. The survey can also be tailored to address issues specific to individual companies.

Sample Questions

The following questions are a sample of the survey statements and are completed on a five point rating scale.

The Regulatory Staff

• Are given too much freedom in their dealings with the agencies.
• Need to do a better job sharing information with the team.
• Are too concerned with pleasing the agencies.
• Review documents in a timely manner.
• Do not use the regulations as a way to limit discussion.

Several of our open ended questions are.

• What do you feel most positive about with regard to the regulatory affairs department?
• How do you think the agency's we work with us would describe our performance

Why use the Regulatory Assessment?

The regulatory assessment provides a unique opportunity to engage other groups in an active dialogue about the department's effectiveness. It ensures that the department is meeting the needs of the organization and provides an excellent follow-up to any management training.

Why the Regulatory Assessment was developed

During workshops and conversations with regulatory affairs professionals, we continually hear that their most difficult negotiations are with co-workers - not agency personnel. We believe that many of these problems are a function of the different perceptions held about the role of the regulatory professional and that these perceptions are not being adequately addressed.

To be effective over both the short and long term, regulatory departments need to educate their stakeholders about their role as well as their interactions with agency staff. In addition, they need continued and ongoing feedback as to their effectiveness. Without regular feedback the department never knows for sure how it is doing.

Training - no matter how good it is - does not answer the question of how the department is viewed. The Regulatory Assessment provides that answer.

Advantages of the Regulatory Assessment

• It allows development of a regulatory strategy that responds to the diverse needs of the organization.
• It tells other parts of the organization that the department is interested in improving its performance and wants outside input.
• It allows problems to be addressed early, thus avoiding major breakdowns in communication.
• Data can be stored and compared over time to allow tracking of departmental progress.
• Since the assessment is completed over the internet, it allows people from diverse facilities to complete the survey.
• It can serve as a training needs assessment.

Special Feature

The survey can also be completed by departmental staff and results compared with the non-department respondents, thus providing an additional basis for discussion. In addition the survey can be tailored to ensure that it is company specific.

When Should the Regulatory Assessment Be Used?

The regulatory assessment is a management tool designed to answer the question, how is the department doing? As such, it can be administered and debriefed at any point.

The Regulatory Assessment is particularly well suited for meetings where the entire department is in attendance and where the feedback can be addressed as a group. Once the data is collected, the results can be used as part of any workshop or training session.

Purchase Options

Several purchase options are available. They include the following:

• Survey Alone - With this option we compile the data for you, but the processing and review of the data is the company's responsibility.
• Telephone Consultation - In addition to the above we will discuss the results with you by phone. We will include our analysis along with our recommendations for follow-up action.
• Debriefing- In this format we conduct the debriefing meeting for you. We will meet with you prior to the meeting to agree on the approach and format.