Arvilla Trag
She is a CMC Compliance and Regulatory professional with over 33 years of experience in biotechnology CMC (Chemistry, Manufacturing, and Controls) and GMP (Good Manufacturing Practices) compliance. She has expertise across all phases, product types, and indications of CMC-related regulatory submissions, strategy, and meetings, from INDs (Investigational New Drugs) to BLAs (Biologics License Applications), including comparability strategies and reports, meeting and pre-meeting packages, CMC amendments, regulatory strategy, FDA responses, and due diligence.
She began her career in 1992 as a lab tech at the NYSDOH. When her grant funding ended, she sought new opportunities and was introduced to a vaccine R&D facility across the Hudson River. Having no prior experience in Regulatory Affairs or Quality Assurance, she was hired at a lower salary—but quickly realized she had found her niche. Six months in, she knew she had discovered her passion, which she continues to pursue today. Over her career, she has had the privilege of working with brilliant colleagues, traveling globally, and helping bring safe and effective drugs to market.
She is a member of the Regulatory Affairs Professional Society (RAPS) and holds RAC (Regulatory Affairs Certified) credentials. She mentors newcomers to the field and conducts workshops in her areas of expertise.
She has participated in the development programs or preparation of marketing applications for approved products including RABVAX®, Oxyglobin™, Hemopure™ (approved in South Africa and Russia), Linsess®, Menactra®, and EBANGA®.
• Regulatory Affairs Certified since 1994
• B.A. Biology/Chemistry, magna cum laude; College of St. Rose, Albany NY
• Regulatory Affairs Professional Society (RAPS)
• Currently establishing a Wildife Studies endowment in memory of my father, Bill Trag, and an endowment for the local animal shelter.
• Established an endowment for music majors in significant financial need at SUNYA in memory of my brother (The Clayton Trag Rock ‘n’ Roll Rebel Award).
What do you attribute your success to?
· Being a one-woman show and a consultant, every project is different, so there is always something new to learn. When a potential client asks me “Can you do X for me?” I (almost) always answer “Of course!” Then I sit down and figure out how to do it.
· I am a perfectionist, and I work as many hours as it takes to get the job done.
· Whenever possible I offer options when the most obvious solution to a problem does not appeal to the client or cannot be done for other reasons.
What’s the best career advice you’ve ever received?
My father gave me three excellent pieces of advice that I live by. First – the only people who don’t make mistakes are people who are not doing anything. Second – don’t price yourself out of the market. Third – don’t believe anything that you hear, believe only half of what you see, and believe only two things that you read: “Men’s Room” and “Wet Paint”.
What advice would you give to young women entering your industry?
Believe in yourself. If you don’t, no one else will. There is no such thing as a glass ceiling unless you believe in it instead of believing in yourself. Never let anyone disrespect you, from cab drivers to CEOs. Politely but firmly say “Is there a reason you are being so rude and disrespectful to me?”
Pragmatism - the only people who don’t make mistakes are people who are not doing anything. Learn from your mistakes and move on. (This applies to daily life, jobs, and relationships.)
Realism – don’t price yourself out of the market.
Common sense – do what you love. You have to work, so you may as well work at something you enjoy (or you will be miserable).
Network – go to every conference you can afford to go to in your area of focus and network. Ask questions during the programs. Find the speakers afterwards and ask questions. Discuss concepts with your peers. You will learn a lot more from real-world experience than from just reading articles.
Pay it forward - Knowledge is only valuable when it is shared – find a mentor, then someday be a mentor. I had no actual mentor when I started in this field; I learned everything by trial, error and reading voraciously. Somewhere out there is a young person desperately in need of your support and knowledge. I am not talking only about career mentoring – share your knowledge on all topics with others. Do you know how to make a killer IPA? Share that knowledge with someone. Do you know how to re-upholster furniture, spin yarn, frame a house, make lighter-than-air souffles, build high-performance engines – by sharing your knowledge, you touch the lives of others. By touching the lives of others, you create a legacy worth more than all the money in the world.
What are the biggest challenges or opportunities in your field right now?
Figuring out cell and gene therapy regulatory strategies. Fortunately, I expect to be retired in just under a year, so I am not focusing on that.
What values are most important to you in your work and personal life?
Honesty: I tell every client at the outset I will never blow smoke up their pantleg, and I will never sugar-coat bad news. I will always be honest to a fault. It is amazing to me how many clients have trouble believing that because they have had other consultants or employees be less than forthcoming with them. They may occasionally not like what I tell them, but they can believe it is the truth.
Authenticity: I say exactly what I mean and mean exactly what I say. (I am not well-suited for work in the diplomatic corps.)
Ethics: I will never, ever let a client – no matter how lucrative – put material in the clinic that I have legitimate reason to believe is unsafe. And I will never share client info with anyone.
Teaching: I love to teach, to share with others the things that bring me joy in the doing. It’s great therapy.