C H A P T E R 1 Introduction
By Peggy Berry, MBA, RAC Q
T
he regulatory profession is not, in my opinion, one of those careers that
kids dream about. In fact, most adults do not even know it exists or what
regulatory professionals actually do. So, how do so many people end up
in the regulatory profession? From my 20 years of experience in regulatory, I can
report that the typical story about entering the profession begins: “It happened by
accident…” or words to that effect. In this book, you will fnd similar stories from
a variety of professionals.
Furthermore, regulatory can be entered from many different directions.
Like spokes on a bicycle wheel that converge on a central point, many paths
lead to the profession. Most professionals have a scientifc background, but
they may have worked in a research laboratory or a quality department, or as
a university professor or a practicing physician before arriving in the regulatory
arena. Educational credentials range from a bachelor’s degree to a doctorate. There
are no hard and fast rules about requirements for a career in regulatory, resulting
in maximum fexibility for applicants and hiring organizations. This book is
structured to provide insights, considerations, tips and ideas for both new and
seasoned regulatory professionals. You will fnd information about some of the
more typical requirements for various levels and types of regulatory positions.
There are a number of different aspects of regulatory work that attract an
individual to this profession. One is the variety of activities and areas available.
At the macro level, one may work with branded or generic pharmaceuticals sold
1
By Peggy Berry, MBA, RAC Q
T
he regulatory profession is not, in my opinion, one of those careers that
kids dream about. In fact, most adults do not even know it exists or what
regulatory professionals actually do. So, how do so many people end up
in the regulatory profession? From my 20 years of experience in regulatory, I can
report that the typical story about entering the profession begins: “It happened by
accident…” or words to that effect. In this book, you will fnd similar stories from
a variety of professionals.
Furthermore, regulatory can be entered from many different directions.
Like spokes on a bicycle wheel that converge on a central point, many paths
lead to the profession. Most professionals have a scientifc background, but
they may have worked in a research laboratory or a quality department, or as
a university professor or a practicing physician before arriving in the regulatory
arena. Educational credentials range from a bachelor’s degree to a doctorate. There
are no hard and fast rules about requirements for a career in regulatory, resulting
in maximum fexibility for applicants and hiring organizations. This book is
structured to provide insights, considerations, tips and ideas for both new and
seasoned regulatory professionals. You will fnd information about some of the
more typical requirements for various levels and types of regulatory positions.
There are a number of different aspects of regulatory work that attract an
individual to this profession. One is the variety of activities and areas available.
At the macro level, one may work with branded or generic pharmaceuticals sold
1