The subject area regulatory affairs ensures that the proof of quality, safety and efficacy of medicinal products is demonstrated to be in line with the legal requirements and solely in the interest of public health.

The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it performs at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.

Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively participating at every stage of development of new medicine and for post-marketing activities of authorised medicinal products.

Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all time post-marketing. The pharmaceutical industry deals with an increasing number of interesting drug candidates and all of them require involvement of the Regulatory Affairs department. Regulatory affairs professionals can play a key role in guiding drug development strategy in an increasingly global environment. But they also play an important operational role for example by giving consideration to best processes to follow and on structured interaction with regulatory authorities. Regulatory affairs is driven by good science and accordingly nothing remains static. Constantly changing subjects are essential features that make Regulatory Affairs a discipline important for companies and also interesting and challenging for individuals aiming at a career in this field.

Regulatory authorities and learned societies also require professionals well-educated in regulatory affairs. Regulatory authorities give advice on development strategies during the development phase, they authorise the start of clinical trial in man, and ultimately grant authorisations to market the product after rigorous scientific assessment of the respective applications. They also ensure safety is maintained by post-marketing safety surveillance and they conduct inspections of product manufacturing sites. For the conduct of these tasks and the scientific review of related dossiers particular knowledge on regulatory principles is required.