Regulatory Affairs - what´s it all about

The Regulatory Affairs department is the face of the Company to the external regulatory environment. We work collaboratively with a wide variety of disciplines, both internally and externally, in an interesting, challenging and demanding environment. Regulatory Affairs is truly very exciting and varied, our aim is to successfully register products with regulatory authorities around the world and to subsequently maintain these licences.

Regulatory people - Who are we?

We guide a product through the sometimes long and winding journey with regulatory authorities. As an international team of professionals who come from varied backgrounds, incorporating different scientific and technical skills, we are responsible for the entire portfolio of products from cradle to grave. Regulatory Affairs is represented on project teams right from the very start of the development of new products to give them best chance of regulatory success. We work within the complex world of human pharmaceutical legislation, using proactive and creative thinking to challenge and bring about the best result for our products, from early stage development right through the post marketing phase.

Approval is the end - Quite the opposite!

It is the beginning of the life cycle of a product which is subject to the ever changing pharmaceutical legislation and internal demands. With a high degree of personal commitment, sense of responsibility and ownership we navigate our products through the challenging regulatory environment. Besides target orientation and a pronounced ability to communicate, the ability to organise and direct diverse activities is what regulatory is about.

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