Clinical Research & Regulatory Affairs

Work Profile of Regulatory Affairs Professionals

Regulatory Affairs  Overview

Regulatory Affairs professionals are of essential importance to the successful development and introduction of novel drugs and devices to the market and make a useful contribution to public health and well-being. Most organizations, irrespective of global, large or small innovative pharmaceutical firms, have departments comprising of regulatory affairs specialists. Other organizations depend on the professional advice of independent regulatory consultants to fulfill their obligations and to ensure everything is in compliance.

Work Profile of Regulatory Affairs Professionals

Regulatory affairs professionals obtain essential paperwork and documentation for regulatory filings. All documents that are a part of the regulatory submissions should be of high quality  and up-to-date. The pharmaceutical sector is a good example of the complexity engaged in regulatory processing. Prior to a drug being officially marketed by a pharmaceutical organization, it must be accepted by the regulatory authorities such as US FDA, MHRA, HSA, CDSCO etc. A regulatory affairs professional who works for a pharmaceutical company generally consults with company researchers and other staff to obtain sufficient data to develop a strong application for regulatory agencies. This data might consist of information on how the drug was developed in a laboratory, how it was analyzed, information about its efficacy and safety profile etc. In some cases, particularly in the case of a new drug, the process takes several years to complete.

The regulatory affairs professionals are responsible to complete all applicable regulatory submission forms issued by the agency, file the forms together with the essential associated documentation and compile a dossier. The particular information requested on submission forms differs significantly based on the type of approval applying for. For instance, the FDA’s Investigational New Drug (IND) application must be presented to the authority by a drug producer prior to the company can perform clinical trials. IND form requests for information concerning the drug protocol, which is basically an explanation of how the drug is designed; data related to the animal studies performed on the drug etc. On the other hand, the FDA’s New Drug Application (NDA) form, which must be submitted before marketing the drug for human use, needs the drug maker to submit additional documentation relevant to the drug’s efficacy and safety in humans, package labeling, manufacturing and other information.

Once submissions have been made the regulatory affairs professionals must monitor the progress of regulatory submissions. It’s important to not only file submissions in a timely manner to start with, but also to follow-up on a periodic basis. Monitoring the progress of submissions is not usually easy. For instance, for a drug company that has a target time frame for getting a new drug on the market, it might be complicated to calculate how much time it will take the regulatory authority to approve NDA application. Sufficient time must be allowed for the regulators to evaluate and approve the application. Usually regulatory agencies will have well published timelines that they take for approvals, so regulatory professionals must anticipate timelines accordingly.

Attending ongoing training courses is usually necessary to keep current on the changing policies and processes. Based upon your organization, this coursework may be provided either within the organization or from external sources. In the case of the pharmaceutical sector, for example, several courses are offered by universities and colleges around the world. Online courses which are more suitable for working professionals are also available. James Lind Institute, for instance, offers the Advanced PG Diploma in Clinical Research & Regulatory Affairs and many other programs. Topics covered in these programs include pharmaceutical sector regulation and compliance with respect to various regulatory authorities, regulatory processes for medical device and veterinary products, and regulatory strategic planning, interfacing & corporate communications among many others.

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