subject: Key Responsibilities Of Regulatory Affairs Department [print this page] Years of research and clinical trials followed by adherence to legislative guidelines and passing through evaluative procedures are necessary before a pharmaceutical company is capable of marketing a drug. The pharmaceutical product development, evaluation and compliance involve numerous steps, and complexities, and professionals working in this field need to take care of diverse tasks.
The responsibility of the regulatory affairs department is much more than acting as the principal link between the pharmaceutical company and the regulatory authorities. While this is the primary task of consultants working in the domain of regulatory affairs contract, there are other functions as well.
The responsibility of the regulatory affairs department does not confine to filing the right forms and submitting to the right authorities. It begins much before the application for approval is filed, right from the initial stages of the product development process. This is necessary to ensure that the final product would be able to pass through the rigorous evaluation tests to establish the quality, safety and efficacy of it.
The Clinical Trials Directive is the authority for contact pertaining to the clinical trial research application in the European Union. Advice regarding adherence to the legislative directives regarding studies necessary before the application is filed also comes within the responsibilities of individuals opting for regulatory affairs jobs.
Pharmaceutical, pre-clinical and clinical trials are essential to support the application filed for approval from the authorities. Input from the regulatory affairs department helps in compliance with the legislation regarding the nature and number of trials for adequate support to the final application. If the number of studies is too many, the research involves waste of time and money; if it is too less, it would be inadequate.
Completion of the pre-clinical and clinical studies and further research work lead to the conclusion of the development programme. Next is the filing of the application. Planning the correct filing strategy and utilising the right methods for it are essential for initiating the evaluation, and trying to enhance the chances of approval.
Strict conformity to the regulations is compulsory, and regulatory affairs ensure that the application submitted does the same along with being consistent, comprehensive and coherent. Compilation of the research data from different departments of the pharmaceutical company and external contractors into a rational whole is an arduous task and it is better to let the regulatory affairs professionals handle it.
Another task of the department is to act as the liaison between the pharmaceutical company and the regulatory authority. Interpretation and application of the regulatory guidelines before the filing of the application is just part of the job responsibility of these professionals. The next task is to coordinate between the two entities.
After the submission of application by the pharmaceutical company, begins a long and meticulous evaluation process by the regulatory authority. In such a situation, the regulatory affairs body is the chief contact between the reviewer and the reviewed. The queries and questions of the reviewing agency are communicated to the pharmaceutical company and answers are supplied from the different departments via this agency.
Regulatory affairs are a comparatively new department in the pharmaceutical field. However, the significance of the responsibilities handled by these professionals makes them an integral body of the entire setup. This is also the chief reason of the increase in career opportunities in this domain.
