From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 10
During the authors’ cumulative 60 years of teaching and working in the pharmaceutical
and medical device industries, questions often have been raised about regulatory as a
career choice. Questions regarding qualifications and prerequisites are most common. At
the beginning of our careers, there were no formal study programs, no Regulatory Affairs
Professionals Society, and the Food and Drug Administration (FDA) had not yet begun
to regulate medical devices. Thus, it was difficult to hire anyone with suitable experience
or a qualified background. Much early education was attained through trial and error.
Unfortunately, that meant learning from mistakes.
With the exception of a few universities, which now offer graduate programs in
regulatory affairs and quality assurance, it is still very difficult to receive a formal regula-
tory education. Therefore, the challenge facing supervisors is how to select and train a
new employee. The supervisor must discharge the responsibility of teaching by using a
combination of on-the-job training experiences and outside seminars and providing the
employee with resources for self-instruction. Motivated employees may continue their
education and ultimately achieve Regulatory Affairs Certification (RAC).
Supervisors can choose from a number of available educational programs to train
a regulatory professional once the person is hired. In addition, the supervisor can take
advantage of the resources described in this article to: foster continuous professional
development encourage career growth and expand capabilities, knowledge and skills.
But, the question still remains—What qualifications do you look for when hiring a regula-
tory professional?
Formal Education
In the pharmaceutical industry, a pharmacy degree may be the ideal prerequisite for a
regulatory career. However, outstanding regulatory professionals have come from many
backgrounds including engineering, law, microbiology, chemistry, biology, medicine and
nursing. To be safe, a job description for a medical device firm would list a degree in
science or engineering as a requirement. By successfully completing a four-year degree
in one of these fields, applicants have proven their ability to undertake and complete a
project spanning several years. Each company must review the education requirements
based on its business needs.
Inquisitiveness
One of the major attributes to seek when hiring a new employee is inquisitiveness. Is the
person inclined to ask questions? Is the person interested in knowing more than the job
requires? Does the individual ask about specific requirements? Questioning is somewhat
analogous to one of the methods used by quality engineers to discover the actual cause of
a problem using a why-why chart. A series of five why questions is used to identify and
differentiate suspected causes from the eventual true root cause.
An inquisitive employee might be interested in knowing more about the food and
drug law from its inception as well as the legislative history of major amendments. New
regulations frequently stem from a disastrous event. The horror stories of thalidomide
and sulfanilamide elixir are two examples of catastrophes that resulted in changes to new
drug approval procedures. Quack devices were in part responsible for the Medical Device
Amendments and their histories make fascinating reading. Books of interest include
Pure Food,1 The Jungle,2 Food and Drug Legislation in the New Deal,3 American Self-Dosage
Medicines—An Historical Perspective,4 The Medical Messiahs,5 The Toadstool Millionaire6 and
The Golden Age of Quackery.7
During the authors’ cumulative 60 years of teaching and working in the pharmaceutical
and medical device industries, questions often have been raised about regulatory as a
career choice. Questions regarding qualifications and prerequisites are most common. At
the beginning of our careers, there were no formal study programs, no Regulatory Affairs
Professionals Society, and the Food and Drug Administration (FDA) had not yet begun
to regulate medical devices. Thus, it was difficult to hire anyone with suitable experience
or a qualified background. Much early education was attained through trial and error.
Unfortunately, that meant learning from mistakes.
With the exception of a few universities, which now offer graduate programs in
regulatory affairs and quality assurance, it is still very difficult to receive a formal regula-
tory education. Therefore, the challenge facing supervisors is how to select and train a
new employee. The supervisor must discharge the responsibility of teaching by using a
combination of on-the-job training experiences and outside seminars and providing the
employee with resources for self-instruction. Motivated employees may continue their
education and ultimately achieve Regulatory Affairs Certification (RAC).
Supervisors can choose from a number of available educational programs to train
a regulatory professional once the person is hired. In addition, the supervisor can take
advantage of the resources described in this article to: foster continuous professional
development encourage career growth and expand capabilities, knowledge and skills.
But, the question still remains—What qualifications do you look for when hiring a regula-
tory professional?
Formal Education
In the pharmaceutical industry, a pharmacy degree may be the ideal prerequisite for a
regulatory career. However, outstanding regulatory professionals have come from many
backgrounds including engineering, law, microbiology, chemistry, biology, medicine and
nursing. To be safe, a job description for a medical device firm would list a degree in
science or engineering as a requirement. By successfully completing a four-year degree
in one of these fields, applicants have proven their ability to undertake and complete a
project spanning several years. Each company must review the education requirements
based on its business needs.
Inquisitiveness
One of the major attributes to seek when hiring a new employee is inquisitiveness. Is the
person inclined to ask questions? Is the person interested in knowing more than the job
requires? Does the individual ask about specific requirements? Questioning is somewhat
analogous to one of the methods used by quality engineers to discover the actual cause of
a problem using a why-why chart. A series of five why questions is used to identify and
differentiate suspected causes from the eventual true root cause.
An inquisitive employee might be interested in knowing more about the food and
drug law from its inception as well as the legislative history of major amendments. New
regulations frequently stem from a disastrous event. The horror stories of thalidomide
and sulfanilamide elixir are two examples of catastrophes that resulted in changes to new
drug approval procedures. Quack devices were in part responsible for the Medical Device
Amendments and their histories make fascinating reading. Books of interest include
Pure Food,1 The Jungle,2 Food and Drug Legislation in the New Deal,3 American Self-Dosage
Medicines—An Historical Perspective,4 The Medical Messiahs,5 The Toadstool Millionaire6 and
The Golden Age of Quackery.7