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The Regulatory Scientist as Liaison

First, as liaison, the regulatory scientist ensures effective and accurate scientific communication between the product development technical units and scientists at the regulatory agencies. This requires timely written and verbal communication through letters, document submission, telephone conferences, meetings, and advising product development teams on agency expectations and requirements, while also providing information to the regulatory agency on progress and proposed changes in the product development plan.

Since the regulatory scientist is the primary communication channel or liaison with the regulatory agencies to discuss product development issues and strategies, the scientist must be well equipped with the relevant technical background, regulatory knowledge, and effective communication and negotiating skills.

The Regulatory Scientist as Strategist

Second, registration the strategist. regulatory scientist is viewed as the product development and Along with other technical members of the product development strategy to guide team, the regulatory scientist develops the regulatory approach or The regulatory product development and registration in the countries of interest. scientist reviews all documents in detail to ensure clarity of data presentation, regulatory accuracy of data interpretation, logic, consistency and compliance with requirements prior to endorsement for submission to the agency. In effect, what the regulatory scientist releases is what gets submitted.

The skills required include comprehension of the technical information to proactively assess data strengths and weaknesses. Also required are: creativity in developing approaches to address weaknesses and rationalize innovative approaches or deviations from established standards; analytical thinking to ensure logic in the flow of data presentation and inferences drawn; and appraisal for scientific rigor and validation of all information provided.

The Regulatory Scientist as Provider of Guidance

Third, the regulatory scientist provides guidance to all functional units involved in the process of product development, manufacture and assembly of data to ensure that regulatory requirements are met and commitments to regulatory agencies are fulfilled.

The product development process involves a cycle which includes discovery, preclinical (animal safety) and clinical development (human trials). The clinical development phase deserves specific mention as the highly complex, resource intensive, extended duration human trials that establish the safety and efficacy of the product and the label claims on how to use the product. During the clinical development phase, there is opportunity to be creative about which clinical design and statistical approaches to use.

Regulatory scientists must have appropriate scientific and medical knowledge to understand these clinical methodologies adequately so they can provide guidance on strategies to optimize the outcomes of the studies and label claims. In addition, they must manage risk assessment, and at the same time ensure compliance with regulatory standards (in addition to the clinical research and statistical functional units). This enables the regulatory scientist to comprehend and augment the clinical development plan and effectively communicate with the medical reviewers at the regulatory agencies through the development of the product. Thus, a technical background that includes advanced degrees in relevant scientific fields can contribute greatly to making the individual in this role more effective.

In conclusion, regulatory scientists are most successful when they can integrate advanced technical knowledge of all aspects of drug development, sound communication, negotiation skills and an effective teamwork approach.

Henrietta Ukwu, MD, FACP, is vice president, global regulatory policy and until recently, was head of worldwide regulatory affairs vaccines and biologics with Merck & Co., Inc. She is an internist and infectious diseases specialist by training.