Mary Y. Jarosz Tell us about your work---what do you do?
I work as a regulatory affairs consultant to the pharmaceutical industry. I aid pharmaceutical companies in preparing scientific documents and meeting requirements to obtain approvals for marketing drugs in countries outside of the United States. What skills are needed?
A background in medical sciences is necessary as well as special training in pharmaceutical regulatory affairs. Many people who provide similar services are registered pharmacists like myself. What was your major?
I obtained a bachelor's degree in pharmacy . This is a minimum five-year program and has recently changed to a usual minimum of six years of college education. Special training for pharmaceutical regulatory affairs can be obtained beyond college education through regulatory affairs professional organizations. How did you get started in your career?
Initially I worked as a pharmacist in an academic hospital setting. I then worked in a large pharmaceutical company in product development before moving into a position in international regulatory affairs within the company. After obtaining experience for a number of years, I started my business and became a consultant in pharmaceutical regulatory affairs. What experience do you need in this job?
Beyond a background in the medical sciences it is necessary to have experience working in a pharmaceutical company in regulatory affairs. Describe your "typical" workday:
I spend part of my day on conference calls with clients in the United States and around the world discussing strategies for drugs that will eventually gain approvals for marketing. Communication with various people within a pharmaceutical company to prepare the documents and strategies necessary for a successful drug application is an ongoing part of my workday. I then spend a number of hours organizing key information and writing scientific technical documents to support the marketing application. Leadership and business related activities are also part of my usual day and include writing proposals for projects, preparing project estimates, and setting goals for the business. What is the hardest aspect of your job?
Project management is a difficult task when working with multiple clients on complicated projects that might span over a year. Organizing applications that can exceed thousands of pages is also a challenge. What is the most rewarding aspect of your job?
Being an expert in my field and being able to provide useful and important insights into the drug registration process for my clients is rewarding. The research that is the basis of all drug applications is fascinating, as is the constantly changing regulatory affairs environment worldwide. I am also rewarded when my clients acknowledge the extra effort that I put into all the projects. What are your suggestions for someone considering this field?
I would recommend that someone interested in pharmaceutical regulatory affairs start with a job in the medical sciences, be it pharmacy, nursing , or medical research. Pharmaceutical companies often have many opportunities for enthusiastic and educated individuals wishing to learn about the drug development and drug approval processes. This background could ultimately lead to a position as a regulatory affairs professional. Good communication skills, technical writing abilities, and a willingness to work with numerous personalities are additional prerequisites.