A Career in Regulatory Affairs

Students with an interest in the Nursing Degree">healthcare and the pharmaceutical industry should consider pursuing a career in Regulatory Affairs (RA).

RA is essential in creating safe and effective healthcare products available to the public. Most pharmaceutical, biologic, and medical device companies have a Regulatory Affairs department or entity within the company that performs regulatory duties ranging from the product development phase to the manufacturing process and the approval and marketing phase.

Products that require regulatory affairs professionals include:
- Pharmaceuticals
- Medical Devices
- In Vitro Diagnostics
- Biologics and Biotechnology
- Veterinary Products
- Cosmetics

RA Professional's Responsibilities

An RA is ultimately responsible for ensuring regulatory compliance within their company and their product.This includes conducting internal audits, working with the Quality Control department to ensure all manufacturing processes, documentation and training records are in compliance with FDA regulations.

RA also works with the Quality Assurance department to track and archive all the necessary documentation to ensure quality assurance and regulatory compliance.

RA is responsible for strategic regulatory development. To accomplish this, RA professionals must keep abreast of current FDA guidelines and regulations.They are responsible for interpreting them and providing other departments with guidance regarding these guidelines.

RA works closely with the preclinical and clinical departments to submit all proper documentation necessary to run the pre-clinical and clinical studies.

RA communicates regularly with the FDA (meetings, teleconferences, etc.) and prepares submissions to the FDA as well as other government institutions and necessary third parties.

RA Educational Requirements

There is no specific undergraduate degree that applies to a career in RA.Students might be advised to attain a bachelor's degree in the following:

Chemistry or Biology - Similar to healthcare professionals, regulatory affairs professionals are likely to have a bachelor's degree in one of the sciences such as biology or chemistry.

Nursing - In most instances, RA works closely with the clinical department, so hiring managers might lean toward hiring nurses and clinicians in their clinical affairs and regulatory affairs departments.

Engineering - Engineering degrees are often looked highly upon due to the technical knowledge involved.

RA professionals are likely to have a degree in a scientific or technical field, but there are successful regulatory affairs professionals with business or liberal arts degrees.An important factor in achieving a career in regulatory affairs is to gain experience in the field.Entry level jobs with titles such as: Regulatory Affairs Assistant, Quality Assurance Assistant, Document Control Clerk and others can often lead to career paths in RA for recent college graduates.

Post-graduate degrees in regulatory affairs are also becoming more abundant in educational institutions.

By Tracy Barton - Freelance Copywriter & Marketing Editor, Amylin Pharmaceuticals

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