Regulatory affairs.If you're finishing your academic career and are looking for a job in biotech or pharmaceuticals, you will have seen a thousand advertisements for regulatory affairs managers.But...what exactly is regulatory affairs?What would I be doing?What sort of skills do I need?What do I need to know before I start?This book answers all these questions and more, providing an introduction to the complex world of regulatory affairs. We cov...

here is a vast step between the laboratory world and that of commercial manufacturing. It is a jump from plate readers and pipettes up to a world of thousand-litre fermenters and raw materials measured out by the tonne. A world where failure can cost millions and where anxious engineers sweat over the slightest variation in pH – and a world which most of us have never experienced before.Written for those still in academia or just having moved into industry, this book will introduce...

Ensure that your advice meetings lead to a positive outcome.Every drug development program has problems. But sometimes more difficult challenges arise. Ones which require discussion with regulatory authorities such as FDA to solve.There is one chance to get this right.One chance to provide your detailed, scientific arguments to the authority and sway them to your point of view. Success means the development program will continue on down the path of your cho...