#21: Successful Drug Development: Best Practices for Drug Development Planning, Agency Interactions, and Regulatory Document Writing
- Vice President, Regulatory Services Management
- Certara Synchrogenix, United States
Elaine Taylor, VP, Regulatory Strategy and Policy at Synchrogenix, a Certara company, has more than 30 years of experience in the pharmaceutical industry and has extensive experience in developing and providing strategic guidance and regulatory advice at all stages of product development. She began her career in nonclinical (pharmacology, toxicology) research and then moved to clinical research and regulatory affairs. Ms. Taylor’s specialties include creating innovative and efficient regulatory strategies for drug development programs, including 505(b)(2) programs, and conducting gap analysis; advising on regulatory agency meetings, responses to regulatory agencies; and preparation and submission of INDs, NDAs, and BLAs.