Pharmaceutical Regulatory Affairs: An Introduction for Life Scientists - Paperback

by C. F. Harrison (Author)

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 cover typical tasks; required skills; the ins and outs of the submission process; vital knowledge you'll need to have; and much more. Lost in a sea of acronyms? We've got you covered. Not really sure how regulatory fits into pharmaceutical development? We explain the process. No idea why your new boss keeps going on about module 3.2.P.7? No problem.

Whether you're looking for a job, preparing for an interview, or have just started in the field, this book will give you the foundational knowledge you need to succeed.

Author Biography

Originally from the sunny shores of Australia, CF Harrison currently works in the beer-filled heart of Bavaria. With a PhD in biochemistry, he has worked in drug discovery, as a scientific consultant, and as a regulatory affairs manager for a major international pharmaceutical company. After being asked many, many times just how life scientists can move into regulatory affairs, he decided to answer these questions once and for all - and thus this introductory book was born. Those interested in contacting him can drop a line to lifeafterlifescience@harrison-scientific.com.