Cheryl Beal Anderson, PharmD, MBA

Cheryl Beal Anderson, PharmD MBA is an expert in pharmaceutical regulatory affairs with a proven record as a subject matter expert in US regulations, guidances, regulatory intelligence to secure drug product approval. Anderson has spent more than two decades in various pharma companies and universities, where she accumulated experience on cross-functional development teams, and served as spokesperson for Sponsor-FDA meetings, labeling negotiations, and post-marketing compliance. She is considered a transformational leader of regulatory affairs, drug safety, and quality functions and develops people to deliver innovative and exceptional results. Anderson has experience with fast-track, accelerated approval, breakthrough designation, priority review programs, orphan diseases, and leading essential FDA- Sponsor meetings throughout the commercial life cycle from Pre-IND, EOP2, pre-NDA, labeling negotiation, Advertising and Promotion, and Post-Marketing Requirement. The therapeutic areas include psychiatry, neurology, oncology, cardiovascular and autoimmune, and generic products. As a corporate executive, Anderson has found solutions for complex business challenges, budget management ($20M), contributor to strategic portfolio decisions, merger & acquisition teams, due diligence assessment for company investments and helps teams generate regulatory strategies to de-risk programs throughout IND phase, NDA prosecution, commercialization, and on-market product maintenance. Anderson has a long-standing commitment to business excellence and diversity, equity, and inclusion company initiatives and employee resource groups.

As former Senior Vice President at Upsher-Smith Laboratories, LLC in Minnesota, Anderson led the Global Regulatory Affairs and Drug Safety, and Quality functions, with special emphasis on the IND/NDA programs and ANDA-marketed products. She was accountable for NCEs in the pre-clinical stage, FIH clinical studies in the US and UK, 505b2 NDA, and generic development, as well as executive liaison for regulatory, safety, and quality Sawai Pharmaceuticals top management in Osaka, Japan. Anderson with IT leadership gained capital to install Veeva Vault Quality Docs/ Quality Management System and Veeva Vault Regulatory Information Management System as a new system to improve company-wide compliance monitoring, identifying/assessing risks and support data-driven decisions.  She also set up a Culture of Quality campaign to increase employee engagement and quality in their jobs. Prior to joining Upsher, Anderson was Senior Director of Global Regulatory Affairs at Lundbeck, Inc for a global cross-functional biologic development team based in Copenhagen, Denmark in acute ischemic stroke. While at Eli Lilly & Company, Anderson was Senior Director, US Regulatory Affairs FDA Liaison group, her team generated strategies for the Cardiovascular, Oncology, and Autoimmune development portfolio. She had the privilege of being a member of the FDA-Pharma Working group that developed the FDA Guidance on the Target Product Profile as a Strategic Communication Tool. Anderson was also the FDA Liaison for neurology and psychiatry development teams at Pfizer Research and Development in Ann Arbor, MI and the regulatory affairs team at Alcon Laboratories, Inc. Anderson was a faculty member from 1986-1993 at the University of Illinois at Chicago and University of Texas at Austin, Colleges of Pharmacy.

In 2013, Anderson became a member of the Center for Healthcare Innovation (CHI), Board of Directors. She is a member of the CHI Development Committee. Anderson has been a CHI symposium panel moderator and executive roundtable facilitator on increasing women and minorities in clinical trials. Anderson has merged social impact and health inequity challenges highlighted by COVID-19 as her personal interest to increase diversity and inclusion in clinical trials. Anderson was recognized as Eli Lilly Healthcare Businesswomen’s Association Rising Star, and the Center for Leadership Development Award in Business. Anderson was a 2021 Honoree of Minneapolis St. Paul Business Journal Women in Business Awards. Anderson is an advisor to the University of Texas at Austin College of Pharmacy and University of Minnesota College of Pharmacy, lecturer and students/fellows supervisor on industry rotations. She contributes to the professional community as a member of the Women’s Business Leaders in US Healthcare, Regulatory Affairs Professional Society and Drug Information Association. She is a member of The Links, Incorporated, the country’s oldest volunteer service organization of African American women leaders.

Anderson is a graduate of Texas A&M University with a BS in Biomedical Sciences. She later entered the University of Texas at Austin, College of Pharmacy where she earned both a BS and Doctor of pharmacy Degrees. Anderson went on to complete an ACPE-accredited clinical pharmacy residency at the University of Texas Health Science Center at San Antonio, University of Texas at Austin, and San Antonio State Hospital, with a specialty focus in psychiatry and neurology practice. In later years, Anderson earned an MBA in pharmaceutical and healthcare marketing at St. Joseph’s University, Philadelphia, PA. Anderson finds balance and inspiration through mentoring and coaching company talent, university students/residents/fellows and high school students to encourage their decisions to choose STEM careers. In her spare time, Anderson enjoys watching select NCAA and NFL football games with her husband, being a mom to her two adult children, taking walks while listening to music and podcasts, and having new adventures through international. Anderson lives with her husband in Spring, Texas, north of Houston, Texas.