dcsimg

Career Story: Regulatory Affairs Executive For A Pharmaceutical Contractor

Regulatory Affairs Executive For A Pharmaceutical Contractor

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.

Job Tips:
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.

Popular Schools offering Management Programs

quickinfoThese schools offer particularly quick info upon request, and we have written detailed profiles for each (click school names to see the profiles).

Request info from multiple schools, by clicking the Request Info links.

Matching School Ads

Liberty University provides a world-class education with a solid Christian foundation, equipping men and women with the values, knowledge, and skills essential for success in every aspect of life.

  • Programs: DBA in Project Management, AA in Business, MA: Executive Leadership, more...
  • Degrees: Doctorate, Associate, Master

Founded in 1911, Southern Methodist University (SMU) is a nationally ranked private university with seven degree-granting schools.

  • Programs: M.S. in Data Science
  • Degrees: Master

Syracuse University’s School of Information Studies (iSchool) - The Original Information School - is proud of its position as a leader in the field.

  • Programs: MS in Information Management
  • Degrees: Master

About Boise State University

Boise State University is a highly respected, public, metropolitan research university offering lifelong learning.

  • Programs: Master of Business Administration
  • Degrees: Master

Founded in 1766, Rutgers, The State University of New Jersey, is a leading national public research university and the state’s preeminent, comprehensive public institution of higher learning.

  • Programs: Online Master of Business Administration
  • Degrees: Master
San Joaquin Valley College
Bakersfield, Delano, Hanford, Hesperia, Lancaster, Madera, Ontario, Salida, Temecula, Visalia

San Joaquin Valley College - A Private Junior College.

  • Programs: Certificate - Business Administration (Management), Degree - Business Administration (Management)
  • Degrees: Certificate, Associate

The University of West Florida (UWF) has a central mission.

  • Programs: Master of Business Administration - General
  • Degrees: Master

Pursue your education at Pacific Oaks College.

  • Programs: M.A. Organizational Leadership and Change
  • Degrees: Master

Welcome to Argosy University

Argosy University offers doctoral, master's, and bachelor's degree programs to students through its eight colleges:  College of Behavioral Sciences, Graduate School of Business and Management, College of Education,  College of Health Sciences, College of Arts and Sciences, College of Creative Arts and Design, College of Clinical Psychology and Western State College of Law at Argosy University as well as certificate programs in many areas.

  • Programs: Management (MSM), Business Administration - Organizational Management (BS) (Online), Business Administration (AS) (Online), more...
  • Degrees: Master, Bachelor, Associate

See What’s Possible When You Earn a Degree at Florida Tech 100% Online

  • Programs: MBA Management, MA in Organizational Leadership, MBA Project Management, more...
  • Degrees: Master, Bachelor, Associate
Matching School Ads

Additional Career Stories for Managers

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.

All Types

You are visiting:

Find a school near you

What are Career Stories?

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:

  • a typical day or project
  • tips and advice
  • best and worst parts
  • educational background
  • previous experience

Browse hundreds of Career Stories

More Details On This Career

Please also see our detailed information about Managers, including:

Back to Top