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

A degree from CTU connects you to what matters most: powerful professional network, real-world professional faculty and innovative technology. Once you earn your degree you hit the ground running.

  • Programs: Bachelor of Science in Management, Bachelor of Science in Project Management, Master of Science in Management , more...
  • Degrees: Bachelor, Master
  • Programs: BS - Business Management, MS - Management, BS - Organizational Leadership, more...
  • Degrees: Bachelor, Master
UEI College
Anaheim, Bakersfield, El Monte, Encino, Fresno, Gardena, Huntington Park, Ontario, Riverside, San Marcos, Stockton

At UEI College, we want you to succeed. We’re like a family and we want you to be a part of it.

  • Programs: Business Office Administration (8-Month Diploma Program)
  • Degrees: Diploma

Push Your Creativity To The Next Level

  • Programs: Innovation & Entrepreneurship, Master of Science (Online)
  • Degrees: Master
California College San Diego
National City, San Diego, San Marcos

The Secret to Getting Ahead is Getting Started

  • Programs: Business Administration - Property Management (BS), Business Administration (BS)
  • Degrees: Bachelor

You’re serious about success. With your busy schedule and the desire to move your career forward, you can earn an accredited associate, bachelors or master’s degree at a pace that works for you anywhere, anytime, 24/7.

At AIU, the Serious U, you can get started to get ahead.

  • Programs: MBA - Project Management, Bachelor's (BBA) - Project Management, MBA - Operations Management, more...
  • Degrees: Master, Bachelor

Congratulations! Your interest in Independence University is an important first step toward changing your life. A career-focused degree is the key to a career with a potentially higher income, better benefits, and more satisfaction.

  • Programs: Business Administration (BS), Business Administration - New Media Marketing (BS)
  • Degrees: Bachelor

Pursue a certificate, master, or doctorate degree in Psychology at The Chicago School for Professional Psychology.

  • Programs: Ph.D. Organizational Leadership
  • Degrees: Doctorate
Platt College
Alhambra, Anaheim, Riverside

Turn your talents into a career at nationally recognized and accredited Platt College.

  • Programs: Business Management
  • Degrees: Associate
San Joaquin Valley College
Bakersfield, Delano, Hanford, Lancaster, Madera, Ontario, Temecula, Visalia

San Joaquin Valley College - A Private Junior College.

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