In honor of RegEx’s 10-year anniversary, we are highlighting the most active members from the past 10 years! Follow along to learn more about these top community contributors.
Say hello to @Linda Bowen
Position: Head of Regulatory Policy and Intelligence
Employer: Seagen, formerly known as Seattle Genetics.
What has been the highlight of your career over the last ten years?
I have had the opportunity to be a part of many exciting projects during my regulatory career including participation in the first FDA Oncology Center of Excellence Project Orbis NME Review as part of the Regulatory Team at Seagen; User Lead and Subject Matter Expert for a Machine Learning Pilot on Regulatory Intelligence; and industry negotiator for two FDA user fees: OMUFA (on behalf of CHPA) and BsUFA III (on behalf of BIO).
On the volunteer side there have been amazing moments as well; winning the RAPS Founder's Award in 2020; Program Chair for 2018 and 2019 RAPS Annual Convergence, leadership roles in the NJ-NY RAPS Chapter since 2003, chairing the DIA Regulatory Affairs Community for 10 years, honored with the 2012 and 2019 DIA volunteer of the year award, volunteer facilitator of a 2-day Regulatory Affairs basics course for PhDs/Postdocs planning to transition to industry, and 20+ years as an Assistant Professor in Temple University Pharmacy School RAQA program.
What makes you most excited about working in regulatory affairs?
Patients are at the heart of everything we do, regardless of where you sit in regulatory affairs. Knowing that we are an integral part of the development of safe, effective, and quality therapeutic products is an amazing feeling and what drives me to get up in the morning!
What is your #1 reason for becoming a RAPS member?
My #1 reason to join RAPS early in my career was to network with other regulatory professionals.
What is your favorite part about RegEx?
The diversity of responses (device, drugs, OTCs) and covered regions. It's the first email I open in the morning!
If you could travel anywhere in the world, where would you go?
I was going to say Australia, been there a few times and would love to go back. But my husband and I have been talking about taking the Alaska State Ferry from Bellingham Washington to Alaska, driving back on the Alcan Highway, visiting relatives in Prince George, Vancouver and Victoria BC and then heading back to our home on the southeastern coast of North Carolina. It requires a few weeks (or months) so we will have to hold off until we are both retired.
What food could you not live without?
Homemade Macaroni and Cheese
What is your go-to karaoke song?
I Dreamed a Dream from Les Miserables.
What piece of advice would you tell yourself in 2011?
I am an information junkie and walking away from work for a proper holiday was very hard for me to do. I would tell my 2011 self not to sweat the small stuff and to learn to disengage and enjoy life.
Favorite book you’ve read this year?
I have not had much time to read non-regulatory books so I'll go with the recent RAPS Publication,"Regulatory Intelligence 101 Third Edition". I authored three chapters and as the book's advisor, reviewed all the chapters and provided commentary.
What is one question you have for the RegEx community?
With respect to your career, where do you see yourself in 10 years?
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Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org------------------------------