Arvilla Trag
Arvilla Trag is a highly experienced CMC Compliance and Regulatory professional with over 30 years in the biotechnology sector. She specializes in all aspects of CMC-related regulatory submissions and strategy, including IND/IMPD and BLA filings, with particular expertise in CTD Modules 3 and 2.3, comparability strategies, CMC amendments, and FDA interactions. Her extensive product experience spans monoclonal antibodies, vaccines, recombinant proteins, ADCs, radio-labeled mAbs, and cell and gene therapies, while her work covers indications such as oncology, HIV, and communicable diseases requiring vaccine development. Arvilla also provides training on technical writing and CTD requirements for regulatory documentation.
In addition to her regulatory expertise, Arvilla is a seasoned CMC QA professional, having conducted over 275 compliance audits including due diligence, vendor qualification, and for-cause audits. She develops and remediates Quality Management Systems, offering GMP training at all organizational levels—from annual refresher courses to executive leadership programs. Her experience ensures organizations maintain the highest standards of compliance, operational quality, and risk management. Arvilla has been Regulatory Affairs Certified since 1994, reflecting her long-standing commitment to excellence in the field.
Beyond her technical and regulatory accomplishments, Arvilla is passionate about mentoring and supporting the next generation of regulatory professionals. She combines her deep industry knowledge with practical insights from decades of hands-on experience, helping companies and start-ups navigate complex regulatory landscapes efficiently. Through her consultancy, CMC Compliance Services, she continues to guide clients in achieving regulatory success while fostering a culture of compliance and continuous improvement.
• College of St. Rose
What do you attribute your success to?
I attribute my success to the example set by my father and the values I was raised with. My strong work ethic drives me, and I approach every opportunity with a “yes, I can figure it out” mindset—if I don’t know how, I take the time to research and learn so I can deliver.
What’s the best career advice you’ve ever received?
The best career advice I’ve ever received came from my father: the only people who make mistakes are the ones who aren’t doing anything. It’s a reminder to take action, embrace challenges, and learn from every experience.
What advice would you give to young women entering your industry?
My advice to young women entering this industry is to believe in yourself—if you don’t, no one else will. Stand firm against disrespect, follow your passions, and always pay it forward by mentoring and teaching others along the way.
What are the biggest challenges or opportunities in your field right now?
One of the biggest challenges in my field right now is navigating communication with other countries regarding U.S. compliance standards, particularly with the FDA. Ensuring alignment across different regulatory environments requires precision, collaboration, and staying up to date with evolving guidelines.
What values are most important to you in your work and personal life?
The values most important to me in both my work and personal life are honesty and ethics. I strive to approach every situation with integrity, ensuring that my decisions and actions reflect transparency, accountability, and a commitment to doing what’s right.