Your First Pharma Job

The Regulatory Science program at the University of Southern California offers a variety of graduate certificates, a Masters program, and a new Doctorate geared towards regulatory affairs professionals. In the Regulatory Science program, students learn how to guide medical products and foods through the complex regulatory and reimbursement paths required to bring them to market. Regulatory Affairs is an incredibly important part of the drug development process, and in a very real sense plays the key role in determining the success or failure of a drug development program. Ultimately, it’s a company’s regulatory affairs team that must make the case to the FDA that a drug is safe, effective, and deserves to be on the market.

The program has posted a PDF scan of a great article on regulatory affairs careers from The Scientist, which is usually only available by subscription. The article, “For the Hottest Jobs - Go Regulatory”, follows a typical day in the life of a regulatory affairs associate, Joan Kwong, who started her career in the laboratory and made a career switch a few years later. The article offers some great insight on career potential and typical salary ranges.

The article also includes a sidebar piece entitled “So you want to be a regulatory affairs professional - here’s how to get started”. The article notes that one of the hardest things to get used to at first is the abundance of industry-specific jargon and acronyms. A great resource for learning the language of clinical research and regulatory affairs is the online glossary hosted by the Applied Clinical Trials journal.  ACT also recently posted an interesting article, “eSubs and eCTD and RPS, Oh My! ” which discusses some of the changes regulatory teams are dealing with as the submission process goes electronic.

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Here’s another great resource for your pharmaceutical job search: Career Opportunities in Biotechnology and Drug Development, by Toby Freedman.

Freedman has put together a solid resource for finding jobs and developing your career in the biotechnology and pharmaceutical industry. At 409 hardcover pages, this isn’t the kind of book you can slip in a pocket to browse on the subway — it’s a comprehensive guide that I could see being an invaluable aide to finding your first job in the biotech industry.

Early chapters on resume writing and interview techniques, including informational interviewing, are brief but well-written and useful. If you’ve read a lot of career guides, these chapters probably aren’t going to teach you anything you haven’t heard before.  The real meat of this book is the industry-specific information that follows.

In an excellent overview chapter, Freedman explains the breadth of the industry, and summarizes the different product development pathways followed by therapeutic, nontherapeutic, and medical device companies.

Next, individual chapters, each about 20 pages long, cover a wide range of career pathways: drug discovery, preclinical research, project management, clinical development, medical affairs, regulatory affairs, quality assurance and quality control, operations, product development, business development, sales, marketing, and corporate communications. Chapters on executive management, legal affairs, finance, management consulting and even recruiting round out this comprehensive guide.

Each chapter includes ’snapshots’ of various roles and offers a thoughtful analysis of both the positive and negative aspects of a given job.  For example, in clinical development, Freedman notes that “Original and applied clinical research is exciting.  Outcomes are unknown until trials are completed, and each trial is unique. Your work is close to the market”, but “There is frequent pressure to meet constantly looming deadlines, and the objectives often seem to be ‘too much, too soon, with too little’”. When you’re just starting out, and trying to decide what path to follow, knowing the downside of a job can be very useful information.

Naturally, salaries and compensation are a matter for discussion, as is the potential for career development, and a look at how future trends might influence job security for each role is useful in today’s economic times.

Perhaps most usefully for job seekers, Freedman clearly lays out job requirements and typical pathways into the role, and offers tips that could be helpful for getting one’s foot in the door.  Descriptions of what it takes to excel in a role, and qualities common to good candidates are also helpful.

This guide isn’t cheap, and it isn’t very portable — but if you are looking for a career in the pharmaceutical and biotech sector, this book should be at your side.

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Signing up for a formal academic program is one way to put yourself on the fast track to a career in pharmaceutical regulatory affairs.

The Regulatory Affairs Professionals Society (RAPS) is a great clearinghouse of information.  If you’re interested in a career in regulatory affairs, it’s a great place to learn more about the role.  Membership isn’t cheap ($185), but it is significantly discounted for current students, and includes a subscription to Regulatory Focus magazine, discounts on educational programs, and access to networking opportunities. RAPS offers online courses that may help give you the knowledge you need to land an entry-level role and maintains a list of degree and certificate programs offered at academic institutions worldwide.

Their career information page includes a number of free articles about the regulatory affairs profession.  One of them explains what to look for if you’ve decided to sign up for an academic regulatory affairs program.

Regulatory Academic Programs: Deciding to Participate and Selecting a Quality Program (this is a PDF file.)

Here are 10 things the article suggests you look for:

1. A diverse curriculum, covering not just drugs but also devices, biologics, and foods and cosmetics.
2. A focus on the practical implementation of regulatory issues. Theory is one thing, real-world applications are another.
3. High-caliber academic staff with extensive, recent, real-world experience in regulatory affairs.
4. Instructional variety, incorporating not just lectures but case studies, multimedia, mock audits and team projects
5. Networking opportunities — a chance to learn and develop connections with your fellow students and instructors.
6. Convenience. Many programs can be completed part-time. Online courses can let you learn from home.
7. Flexibility.
8. Supportive administrative staff.
9. Affordability.
10. Reputation.  A certificate from “Joe’s Auto Lube and Reg Affairs Academy” won’t have the same value as successful completion of a program that’s known and respected by the industry.

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