I began my career in the US Food and Drug Administration’s (FDA) Office of Tobacco Programs but quickly moved into the Office of Policy in the Office of the Commissioner. In this role, I was involved in a wide range of policy issues, including drug advertising, labeling and promotion, medical device user fees, tobacco regulations, and food safety.

My most memorable moments at FDA were the briefings we would do for the HHS Secretary, which required a few long days and quite a lot of teamwork. Luckily we had “all-star” caliber employees at FDA that made things work seamlessly. I was very young in my career then and, honestly, naive to how these types of activities would help prepare me for what was to come next in my career in terms of the level of preparation, required expertise and collaboration necessary to be successful.

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Currently, I am the Global Regulatory Lead for multiple Tier 1 products in AstraZeneca. I lead the Global Regulatory Strategy Team Andincluding regional regulatory affairs directors, CMC regulatory directors, and regulatory project managers to support the research, development and commercialization of products across both small molecules and biologics for different therapeutic areas.

I was in the FDA CDER office of biostatistics for 13 years and became an FDAAA Associate Member three years before I left the Agency. My No. 1 reason for joining the FDAAA was the great mentorship and valuable career advice I received from many FDA alumni. Once an FDAer, always an FDAer. In this diverse and close-knit network of professionals, we are all connected by a common thread of having worked at the Agency, and we all embrace the FDAAA’s core mission - helping alumni stay in touch with the issues of the day facing the FDA and supporting the agency's public health mission.

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The FDAAA wishes to Thank Dr. Fauci

You might have noticed Dr. Fauci has been in the forefront of dealing with the Coronavirus Crisis and COVID-19. In 2018, The FDA Alumni Association presented our most prestigious Harvey W. Wiley award to Dr. Anthony Fauci, MD. Dr. Fauci represents the best qualities in our career federal scientists. Our association is proud to recognize him for all that he does for every citizen in this country. Dr. Fauci is the Director, National Institute of Allergies and Infectious Diseases, within the National Institute of Health.

For more information, click here to read the FDAAA Annual Report - 18th Edition.

The FDAAA Alumni Advisor Program

The FDA Alumni Association Advisor Program's (FDAAP) mission is to assist current Agency managers in becoming more knowledgeable, skilled and effective in leadership roles. In partnership with the FDA Alumni Association and the Office of Personnel Management (OPM), FDAAAP pairs respected retired FDA/ORA Managers (Advisors) with FDAAAP participants, current ORA supervisors/managers (Learners), in an open, trusting and confidential mentoring relationship. The goals of this relationship are to share knowledge, experiences, organizational values, and encouragement with Learners in the continued development of management techniques, desired behavioral traits and leadership competencies.

For more information, click here to read the FDAAA Annual Report - 18th Edition.

I was part of the FDA family for nearly 25 years, having served in several leadership positions, the last of which was the Associate Commissioner for Regulatory Affairs. The best part of being an FDAer was working with exceptional people with a deep commitment to the agency’s mission and the real sense of community – a regulatory, law enforcement, public health community. That cuts across all disciplines, as it is truly an integral part of the fabric of FDA. 

That is something I deeply miss….the people. On December 31, 2019, I retired from FDA and a total of 35 years in public service. The tragic ongoing global pandemic hit very soon after I retired and those first months were quite difficult, as I had a very strong drive to return to the agency and stand with colleagues as they tackled an unprecedented public health challenge. 

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