C HOOSING THE R IGHT R EGUL ATORY C AREER
by prescription or over the counter, with biologics or with medical devices that are
new or substantially equivalent devices. One may perform regulatory duties at global
or regional companies of any size. In addition, the company or the professional
may focus on a specifc therapeutic area. In this book, you will read about the
experiences of regulatory professionals working in various types of organizations and
different product areas. The authors also compare and contrast these work areas and
organizational types with their own experiences, and share guidance and tips.
Another consideration for regulatory professionals is whether to specialize
in areas such as chemistry, manufacturing and controls, advertising or labeling,
or to remain a generalist. Several of the authors describe requirements for
specialization and the benefts of doing so, as well as their own career choices.
Each specialty area, type of company and product development sector has
characteristics that are more or less appealing to each individual.
Personally, I have worked for the government, contract research
organizations, biotechnology companies and small and large pharmaceutical
frms. I have specialized in one area and otherwise been a generalist. In gaining
all of these experiences, I learned that that I prefer working at small to medium-
sized companies because I like performing a large variety of tasks and having a
clear, visible impact on a given project or organization. I also am inclined toward
change and continuous improvement and fnd fulfllment in changing jobs
every four years or so. New roles allow me to learn from other professionals—
within regulatory and other areas of the company—and gain new and diverse
experiences that expand my overall regulatory knowledge.
There are three lessons that I have found most valuable throughout my
career.
Listen and Learn
No matter what you are doing or how long you have been doing it, you
will always get further ahead if you listen to those around you and adjust your
response or reaction accordingly. I fnd that listening is one of the most effective
tools that a regulatory professional can master. It helps in dealing with project
teams, senior management, direct reports, contractors, consultants and FDA or
other regulatory authorities. Every person comes into a situation with a certain
set of biases and assumptions. It is important to intentionally minimize your
own biases and challenge your own assumptions to be open to and fully aware
of other people’s perspective—whether you ultimately agree with it or not.
Learning this skill will be helpful early in your career to fully understand what
is expected of you, and it will be helpful later for many reasons, including fully
understanding the regulatory agency’s viewpoint and priorities.
2
by prescription or over the counter, with biologics or with medical devices that are
new or substantially equivalent devices. One may perform regulatory duties at global
or regional companies of any size. In addition, the company or the professional
may focus on a specifc therapeutic area. In this book, you will read about the
experiences of regulatory professionals working in various types of organizations and
different product areas. The authors also compare and contrast these work areas and
organizational types with their own experiences, and share guidance and tips.
Another consideration for regulatory professionals is whether to specialize
in areas such as chemistry, manufacturing and controls, advertising or labeling,
or to remain a generalist. Several of the authors describe requirements for
specialization and the benefts of doing so, as well as their own career choices.
Each specialty area, type of company and product development sector has
characteristics that are more or less appealing to each individual.
Personally, I have worked for the government, contract research
organizations, biotechnology companies and small and large pharmaceutical
frms. I have specialized in one area and otherwise been a generalist. In gaining
all of these experiences, I learned that that I prefer working at small to medium-
sized companies because I like performing a large variety of tasks and having a
clear, visible impact on a given project or organization. I also am inclined toward
change and continuous improvement and fnd fulfllment in changing jobs
every four years or so. New roles allow me to learn from other professionals—
within regulatory and other areas of the company—and gain new and diverse
experiences that expand my overall regulatory knowledge.
There are three lessons that I have found most valuable throughout my
career.
Listen and Learn
No matter what you are doing or how long you have been doing it, you
will always get further ahead if you listen to those around you and adjust your
response or reaction accordingly. I fnd that listening is one of the most effective
tools that a regulatory professional can master. It helps in dealing with project
teams, senior management, direct reports, contractors, consultants and FDA or
other regulatory authorities. Every person comes into a situation with a certain
set of biases and assumptions. It is important to intentionally minimize your
own biases and challenge your own assumptions to be open to and fully aware
of other people’s perspective—whether you ultimately agree with it or not.
Learning this skill will be helpful early in your career to fully understand what
is expected of you, and it will be helpful later for many reasons, including fully
understanding the regulatory agency’s viewpoint and priorities.
2