Career QnA

Read about the career choices our mentors have made to become established biotech professionals. Each month, a new mentor will share their career journeys and advice for those wishing to follow in their footsteps.

Karen Long

Ashraf Amlani - Monday, January 31, 2011

Karen Long is Regulatory Affairs Specialist at Angiotech Pharmaceuticals. Angiotech is a pharmaceutical and medical device company that discovers, develops, and markets innovative technologies and medical products primarily for local diseases or for complications associated with medical device implants, surgical interventions and acute injury. Working in regulatory affairs, Karen get to see all the R&D efforts come together as a project gets submitted to the relevant regulatory bodies. A large part of her day is devoted to technical writing or reviewing documents. Along with Regulatory Affair Certification (RAC) in US, EU and Canada, Karen has a M. Sc in Pharmaceutical Science and a B. Sc in Chemistry from the University of British Columbia. If Karen could go back in time, she would like to meet Carl Sagan, a scientist and the author of “Cosmos”. She attributes her devotion to the life sciences to watching Cosmos at the tender age of 13, but wonders if she would have become a pharmacist or an accountant, has she been more pragmatic.

SBN: Describe a typical day at work
AngiotechKL: Most of my colleagues operate in the Eastern time zone. So by the time I turn on my computer in the morning there are dozens of emails. By 2 pm, the email buzz starts to dwindle and most of my project meetings are finished, so I can do “real” work. Real work can be extremely variable, but usually involves some sort of technical writing or review of documents or research on a new requirement or product. Documents are the food of the regulatory affairs professional. 

On a good day, I get to publish a submission to a regulatory body like the FDA, Health Canada or our Notified Body in Europe. This is always a big milestone for the product/project. Submissions can range from a 1 page letter to a 250-volume clinical trial.

SBN: What do you enjoy the most about being a Regulatory Affairs Specialist?
KL: I like the variety. There is a new product or a new regulation or a proposed change all of the time. We are constantly learning. The best part of Regulatory Affairs is that it comes at the end of the development process, so you get to see everything come together for a big submission. And we’re also the first members of the team to find out when the product has been approved for marketing!
Karen Long
 SBN: What challenges did you encounter while establishing your career and how did you overcome them? 
KL: I didn’t know anything about Regulatory when I started!! I could quote the FDA’s stability regulations backwards, but there is a world of regulation out there: drugs, devices, in vitro diagnostics, veterinary products, combination products, cosmetics, natural health products… pre-clinical, clinical, manufacturing, labeling, post-market surveillance, promotion… and then there are the jurisdictions… US, EU, Canada, Japan, the ASEAN countries and South America. There are a LOT of regulations in the world, and they change all of the time. Once I joined the Regulatory department, my manager suggested that I take the Regulatory Affairs Certification (RAC) exam. It gives you a broad overview of the regulatory scheme in a particular jurisdiction. So I earned my US RAC in 1999, and have slowly picked up the European, Canadian and General Scope certifications. It gets easier once you have a bit of experience. 

SBN: Any advice you would like to share with those pursuing a career in biotech?
KL: Keep learning all the time. Biotech can be unpredictable. Be prepared for a major shift, in your project, your role or your company, at least every two years. But you will be amazed at your own flexibility. 

Also, we have a wonderful local resource in LifeSciences BC. Check out the employment page to see who’s hiring and what qualifications they’re looking for. And be sure to attend some local events to broaden your network.  

Student Biotechnology Network on LinkedIn

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