Job Title: Vice President, Regulatory Affairs
Type of Company: I work in the pharmaceutical industry for a company that is involved in contract research and development, contract manufacturing and packaging, and contract analytical services.
Education: BS, Biology, Rider University MA, Management, Central Michigan University MT(ASCP) certification, American Society of Clinical Pathologists RAC (Regulatory Affairs Certification), Regulatory Affairs Professionals Society
Previous Experience: I began my career as a clinical microbiologist and quickly found employment with pharmaceutical companies, working as a microbiologist in R&D. In time, I moved into Quality Assurance management and then Quality Assurance and Regulatory Affairs. Once in management, I ascended the ladder from Associate Director to Director to Sr. Director to Vice President.
Job Tasks: My primary responsibility is to provide regulatory consulting services to the various divisions of my company or to our customers. Our clients are pharmaceutical companies which outsource their regulatory affairs work to our company, work whose primary focus is obtaining FDA approval for new or experimental drugs.
On any given day, I can be contacted for my input on how the company or our client should proceed in surmounting a regulatory hurdle or developing a successful strategy for gaining FDA approval for a product. In fact, I will often be called on to act as liaison and primary contact with the FDA in discussions we hold with them regarding approval of a client's new drug. In that capacity, I arrange and conduct meetings with the FDA and try to figure out what the FDA requires and communicate this to the lab so that experimental data can be formatted to suit. I write or oversee the writing of so-called NDA's (new drug applications) and help to compile the regulatory data that's submitted to the FDA in support of those applications. Much of my work is involved with the interpretation of FDA rules, with helping design studies that will answer all of the FDA's questions and then assembling the scientific information into an easily understandable package that will garner their approval.
Best and Worst Parts of the Job: The best part of the job is that you get to research what is needed to gain approval of a product from the FDA and translate that into terms the scientists and researchers can work from. To understand what is needed for product approval usually involves in-depth technical analysis, talking to lots of people, reviewing FDA regulations and guidelines and scientific documentation.
The worst part is writing up the supporting documentation that defines and summarizes the analytical and clinical research in a way that's clear and comprehensible. It's more fun to develop the strategy for gaining approval than it is to write about the studies.
1. Take as many courses as you can in your scientific discipline and in data structures or technical writing.
2. Develop good communication skills and make sure you consider joining an organization such as Toast Masters so you can hone your presentation skills.
3. Consider graduate work in regulatory affairs. Some universities now offer a Masters in Regulatory Affairs.
Additional Thoughts: The most important personal qualities you'll require are a zest for detail and good organizational and communication skills. I regret sometimes that, when I started out, there were no masters programs in Regulatory Affairs. If there had been, I would have pursued one.
Click the Visit School Site buttons to go directly to a school's website and learn more about the school and programs it has to offer. School website will open in a new tab. .
Click the Request Info buttons to request more information from a representative at the school
CSU Global Campus - Management Information Systems & Business Analytics
MBA@Simmons is the Master of Business Administration program delivered online from Simmons School of Management.
Turn your talents into a career at nationally recognized and accredited Platt College.
Pursue a certificate, master, or doctorate degree in Psychology at The Chicago School for Professional Psychology.
The Secret to Getting Ahead is Getting Started
You can advance your career with a degree from Charter College Online.
Since 1888, The University of Scranton has grounded its education in Catholic and Jesuit principles based on intellectual growth and integrity, all of which shape the online master’s and certificate programs.
What They’re Known For
Founded in 1946 and located in the heart of central New York, Utica College is a regionally accredited, independent, private institution that features many of the advantages of a large university — such as undergraduate and graduate degree options, excellent academics, and outstanding faculty — with the intimacy and high degree of personal attention more closely associated with smaller private institutions.
Pursue your education at Ohio Christian University.
Baker College is proud to be the largest independent college in Michigan with the most focused approach to education and training available. With one of the highest graduate employment rates in the country, our mission is to help our students find meaningful employment.
The inside stories from people actually working in the field.
Click a story title to show the story, and click the title again to hide it.
Career Stories are concise, real-world career overviews written by people relating their personal career experiences and wisdom. They provide invaluable insights and mentoring advice to students and career changers.
Most stories include:
Please also see our detailed information about Managers, including: