Monica Brown

About Monica Brown

Monica Brown has over 15 years of experience in Regulatory Operations and Management, successfully publishing original and lifecycle IND, NDA, MAA, BLA, DMF, ODA and CTA submissions for multiple therapeutic areas including Oncology, Neuroscience, Rare Disease and, Gastroenterology. Expert level knowledge of PDF submission-readiness including document tracking and preparation of electronic regulatory submissions. Experienced with source document formatting, PDF conversion, scanning, PDF page stamping, bookmarking, hypertext linking and media preparation. Globally, Monica has worked with local operating partners to submit compliant eCTD, NeeS and CTD submissions to various regions including: US, Canada, APAC, CIS, LATAM EMEA and GCC.With working knowledge of several publishing tools and validation tools, Monica enjoys working in Regulatory Operations!In 2022 (Q1), Monica managed a team of four publishers to submit 3 Initial NDAs (Note: Two of the NDAs were submitted on the same day). She also submitted two Initial INDs, in parallel, with highly abbreviated timelines.Also in 2022 (Q4), Monica was honored to be voted \'Best Manager\'(Global Regulatory Operations).

Experience

1. Director, Regulatory Operations

   Relay Therapeutics

   Apr 2023 — Present · Boston, MA, US

   Oversight of Publishing• Develop Submission Processes and Best Practice for IND, NDA, CTA, BLA and, MAA submissions• Vendor ManagementCollaborate with Medical Writers• eCTD Templates• Submission ReadinessCollaborate with Quality Team• Regulatory Operations SOPs and Job AidsCollaborate with Regulatory Affairs• Forecasting• Publishing StrategiesVeeva• Partner with IT to execute the Veeva Implementation Plan• Internal Trainings• System Owner