Sarah Mcnulty

Biography

 Over 15 years of experience in Clinical and CMC aspects of Regulatory Affairs in the context of pharmaceutical drug and biological product development. Areas of expertise include: NDA submission process in eCTD format; interacting with FDA from pre-IND stage through post-NDA submission; the IND and CTA submission process, including preparation and submission of initial applications, clinical protocols and protocol amendments, Investigator Brochures, annual reports, nonclinical and CMC information amendments, expedited safety reports, and meeting requests and information packages; review of clinical, CMC and nonclinical information for submission; GCP requirements; regulatory intelligence; and regulatory and clinical filing systems. Strengths include: excellent communication, problem solving and organizational skills; ability to work efficiently and effectively on cross-functional project teams; and facility for multi-tasking and consistently meeting submission timelines and goals.

Research Interest

 Clinical Studies, Molecular Biology