Regulatory Affairs Specialist

Regulatory Affairs Specialists work to ensure that biotechnology or biopharmaceutical products meet all the quality attributes — safety, efficacy, potency and purity — required by customers and regulatory agencies.

 

Summary

According to Corinne A. Marasco, C. Washington and E.N. Washington of Chemical and Engineering News, "the pharmaceutical industry is the most regulated of all industries" and it's the regulatory affairs specialists (also known as quality assurance associates) who see that those regulations are met. Their work has wide ranging implications. Not only is it their job to protect the health and safety of the public, but to navigate the company's business plan, the government's continually changing policies, the ethics of production and interests of the medical research community.

Regulatory affairs specialists or quality assurance associates can work in the biopharmaceutical or biotechnology industries. In the pharmaceutical world, these professionals manage all the red tape surrounding a drug's successful approval and release. They coordinate with scientists and pharmaceutical officials to plan drug trials, facilitate drug research and interpret and report data to regulatory agencies. They make sure all activity that occurs within a drug's lifespan meets state and federal guidelines. They apply for all necessary approvals and marketing permits from the FDA as well as international regulatory offices, and track, obtain and renew any required permits and licenses. These duties can be as broad as setting up a drug trial or as minute and specific as indicating what information must appear on a drug's label. Any activity that falls within the realm of a drug's approval is fair game for a regulatory affairs specialist.

Learn more about their role in the biotechnology world.

 

Educational Requirements

In order to work as a pharmaceutical regulatory affairs specialist, most companies require a minimum of a Bachelor's Degree in science, preferably in chemistry, biochemistry, pharmacy, pharmacology, or pharmaceutical technology. The number of programs offering master’s degrees in QA and Regulatory Science is increasing as well.

 

Median Salary 2018

$105,352

 

Want to know more?

About Bioscience - Quality Assurance

Science Careers-Regulatory Affairs

University of Kent-Regulatory Affairs

 

Get Connected

Belonging to professional organizations & LinkedIn groups can provide you with networking, informational interviewing, & job shadowing opportunities, as well as assist you with finding internships and jobs.

Regulatory Affairs Professionals Society

Regulatory Affairs Professionals Society LinkedIn Group

Pharma, Biotech, Life Sciences & Medical Devices Jobs on LinkedIn

Quality Assurance LinkedIn Group

List of Professional Organizations

The Career Connector for Purdue College of Science Students & Alumni

 

Get Experience

Research & Internship Listings

 

Find a Job

Regulatory Affairs Jobs on LinkedIn

RAPS Career Page

QA and QC Jobs on LinkedIn

Job Search Sites Related to Your Major

 

Information retrieved from http://www1.salary.com/Regulatory-Affairs-Specialist-IV-salary.html, http://www.biospace.com/News/pharmaceutical-regulatory-affairs-jobs/166073 , http://www.aboutbioscience.org/careers/quality-assurance-associate/

Purdue University College of Science, 150 N. University St, West Lafayette, IN 47907 • Phone: (765) 494-1729, Fax: (765) 494-1736

Student Advising Office: (765) 494-1771, Fax: (765) 496-3015 • Science IT, (765) 494-4488

© 2015 Purdue University | An equal access/equal opportunity university | Copyright Complaints

Trouble with this page? Disability-related accessibility issue? Please contact the College of Science Webmaster.