Regulatory

A Day in the Life of a Regulatory Affairs Associate

Regulatory Affairs Associates are of pivotal significance to the successful development and bringing to the market of new products that are safe and make a worthwhile contribution to public health and welfare. Most companies, whether they are major multinational pharmaceutical, medical device or diagnostic corporations or small, innovative biotechnology companies, have specialist departments of regulatory affairs professionals. Other companies rely on the expert advice of independent regulatory consultants to meet their obligations.

A day in the life of a Regulatory Affairs Associate is varied as they perform different roles at different times, depending on what stage they are up to in their products journey to market. In general, the regulatory affairs professional must advise on ever evolving legal and scientific requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating. They are frequently called in to advise on the differences that exist in the regulations laid down by different governments and their interpretation by the regulatory agencies, thus ensuring that efficient and economical research and development programmes are planned. They are responsible for the presentation of registration documents to regulatory agencies, or notified bodies, carrying out all the subsequent negotiations necessary to obtain and maintain marketing authorisation for the products concerned. Beyond registration they ensure compliance with reporting responsibilities and input into the clinical and commercial debate on how the product will develop further. They provide strategic and technical advice to the highest level in their companies from the conception of the development of a product through to advice on the packaging and promotional material.

Regulatory Affairs Associates need to use communication, research, project management, analytical, interpretation and negotiation skills, as well as diplomacy, business sense and integrity on a daily basis. A good regulatory affairs professional will also have a right first-time approach and will play a very important part in coordinating scientific endeavour with regulatory demands throughout the life of the product, helping to maximise the cost-effective use of the company’s resources. Although a Regulatory Affairs professional requires a scientific mind and knowledge of the law, there is also an element of interpretation and inspiration essential for this role. In short, Regulatory Affairs Associates are involved in the success of not only the product, but the company as a whole.

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