Antonio Cecilio

About Antonio Cecilio

At Beam Therapeutics, my focus as a Senior Manager in Regulatory Information Systems lies in enhancing the efficiency of regulatory submissions. My responsibilities include managing global submissions and ensuring seamless system implementations. With a Veeva Business Administrator certification, I specialize in using Veeva Vault for documentation control, contributing to the meticulous management of regulatory correspondence and archives.Collaborating with cross-functional teams, I have a proven record in developing processes that uphold the integrity and timeliness of submission content from conception to completion. Our team\'s commitment to detail ensures accurate tracking and quality control, providing steadfast support to program teams within the dynamic landscape of pharmaceutical regulatory affairs.

Experience

1. Sr Manager, Regulatory Information Systems

   Beam Therapeutics

   May 2024 — Present · Cambridge, MA, US

   Provides direct support to program teams and functional disciplines responsible for developing and delivering components for regulatory submissions.• Manages all aspects of global submissions including submissions portals access, publishing, validation, and Regulatory system implementations.• Interacts with and monitors vendors to support publishing and systems.• Organize and maintain regulatory correspondence and archives to prepare for migration into RIM system.• Develops and manages day-to-day submission plans in accordance with program timelines in collaboration with CRO publishing partners.• Develops processes and works collaboratively with other functions including Information Technology to maintain, optimize, and implement systems for electronic submissions and publishing in a validated state.• Works across all disciplines to develop and maintain a comprehensive set of e-submission document templates• Serves as the administrator for Beam’s regulatory information management system and provide Subject Matter Expertise to support project teams in the development of components for various regulatory submissions.• Develops and maintains efficient tracking mechanisms for all global regulatory information including the archiving and storage of both electronic and hard copy records (if applicable).• Monitors evolving global regulatory guidance/regulations and ensures Beam’s regulatory submissions comply with all document/file formats and structures• Authors and/or collaborates on standard operating procedures for the regulatory operations function.• Perform other related duties as assigned.

Skills

• Firstdoc
• Regulatory Affairs
• Quality Assurance
• Spanish
• Sharepoint Administration
• Insight Publisher
• Bilingual
• Document Management
• Electronic Common Technical Document (Ectd)
• Formatting Documents
• Document Review
• Customer Support
• Regulatory Requirements
• Pharmaceutical Industry
• Spl
• Leadership
• Microsoft Office
• Publishing
• Isi Toolbox
• Microsoft Word
• Computer Science
• Compilation
• Customer Service