Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Languages
Websites
References
Timeline
Generic

Daysi Figura

Brewster

Summary

Regulatory Operations professional with 20 years of experience in the pharmaceutical industry, specializing in document management systems and global electronic submission processes. Proven track record in systems validation testing and training for internal and external teams. Experienced in managing teams of up to 8 staff members, leading projects, and ensuring quality assurance. Strong leadership and communication skills, with a focus on driving operational efficiency and enhancing team productivity.

Overview

23
23
years of professional experience
1
1
Certification

Work History

Sr. Manager, Regulatory Systems Business Support, Regulatory Operations

CRISPR Therapeutics Inc.
Boston
12.2020 - 03.2025
  • Certified Business Administrator, System Administrator and Trainer for Veeva Vault RIM. Main business contact with IT, vendors and service providers on systems-related issue resolution, implementation of new configurations, system maintenance and upgrades.
  • Acted as key expert during the implementation of Veeva Vault RIM including authoring/executing OQ/PQ test scripts, developing training plan and training all staff throughout the company.
  • Responsible for all RIM training initiatives at CRISPR such as providing training eLearning modules, training plans including training execution.
  • Lead the CRISPR Veeva RIM Business Change Control Board User Group to ensure business processes are developed for each department, provide technical expertise, and implement configuration updates to support business needs.
  • Collaborated with RA Operations, Regulatory Leads, CMC Team, Quality, Research and Clinical teams to establish efficient, high quality submission publishing methods by evaluating existing systems and processes and delivering solutions for new processes.
  • Responsible for end user account processing and user account maintenance, as well as coordinating with IT on security and access needs.
  • Represented Regulatory Affairs Department as Training Coordinator and ensure that appropriate training (beyond RIM training) is assigned to Regulatory staff during their onboarding process.
  • Authored SOPs and Working Instructions associated to regulatory submissions and supporting documents Using Veeva RIM.
  • Provide support to multi-site end-users by understanding and ensuring their needs are met and escalating more complex queries and issues to IT or Veeva Support.
  • As an expert in RA Technology Systems functionalities (e.g. StartingPoint MS Word Template Use, ToolBox, Digital Signatures, PleaseReview), implement technologies, plan, manage and deliver end user training to groups or individuals.
  • Lead activities related to setting standards, best practices, KPIs collection, developing new procedures and work instructions, and lessons learned dissemination.
  • Author test scripts and perform validation testing on RIM system.
  • Monitor the development of new regulatory requirements or guidance and provide advice to Regulatory Operations and Regulatory Affairs of the business impact.
  • Coordinated with IT department to implement new technologies and systems enhancements.
  • Produced thorough, accurate and timely reports of project activities.
  • Ensured compliance with applicable laws, regulations, policies, and procedures across all business units.
  • Coordinated with internal departments to ensure successful execution of projects according to timeline and budget constraints.

Senior Manager of Regulatory Operations

TARGET HEALTH LLC
New York
04.2017 - 12.2020
  • Managed the Regulatory Operations staff comprised of 6 direct reports who worked on submission projects for over 90 clients.
  • Regulatory Operations key representative for cross-functional working teams for projects related to electronic document management and regulatory submissions.
  • Worked closely with clients, consultants, as well as with colleagues at Target Health to maintain submission timelines.
  • Managed the formatting, publishing, QC, and compilation/assembly of electronic and/or paper submissions in the appropriate formats (i.e., eCTD) for submission to a Regulatory Agency including, but not limited to, IND’s, NDA’s, BLAs, MAAs, ODD and 510k.
  • Responsible for the regulatory submission content and submission timelines for major applications for various clients utilizing eCTD Content Plans to track documents and data, document delivery, publishing tasks, QC and final delivery to Regulatory Agency.
  • Managed submission approval status in Target Document for timely submission to Agency.
  • Submitted eCTD submissions through the ESG for clients.
  • Ensured that all aspects of electronic submissions meet Regulatory Agency and Target Health submission standards and technical requirements.
  • Developed and maintained procedures, checklists, and where necessary, SOPs, to document and streamline the work of the Regulatory Operations group.
  • Managed permissions and user access in Target Document Management system.
  • Worked with clients, consultants, as well as with colleagues at Target Health regarding submissions to a Regulatory Agency.
  • Assigned work and monitored performance of project personnel.
  • Implemented new software and technology in support of electronic submissions per ICH and FDA guidances.
  • Conducted regular performance appraisals for direct reports to provide feedback on their work performance.
  • Held regular one-on-one meetings with employees to review performance and priorities and provide feedback.
  • Conducted performance reviews and provided feedback to direct reports for career development.
  • Participated in recruitment initiatives by interviewing potential candidates and selecting suitable hires.

Associate Director, Regulatory Operations

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
Ridgefield
08.2014 - 11.2016
  • Supervised Regulatory Affairs Operations staff on preparation of Investigational New Drug (IND), New Drug Applications (NDA), Biologics License Applications (BLA), Marketing Authorization Application (MAA), Drug Master File (DMF) applications and life-cycle management.
  • Monitored, and ensured timely delivery/dispatch to regulatory agencies.
  • Served as main point of contact with IT to ensure ongoing support to regulatory systems.
  • Delivered support as System Owner, Test Administrator, System Administrator and Subject Matter Expert.
  • Led the implementation of updated US Mod. 1 specification.
  • Gathered software/business requirements, ensured system upgrades, prepared sample submissions to FDA, authored business processes and training materials.
  • Launched a process for storing and retrieving electronic case report forms (eCRFs) in BI’s Electronic Document Management System (DMS) by automating repetitive tasks which increased productivity and preparation time of CRFs by 80%.
  • Redesigned the process for providing electronic submission strategy in Pre-NDA or Type C Meeting Packages, implementing a consistent approach across all therapeutic areas to eliminate technical errors during submission.
  • Participated in implementation of Regulatory Information Management (RIM) system and new eCTD tool.
  • Created system/user requirements for submissions to FDA and Canada.
  • Hired external staff for publishing, dossier publishing and archiving services.
  • Co-authored Scope of Work, Service Level Agreements, Key Performance Indicators and contracts.
  • Ensured timely training and technical support and evaluated team’s performance.

Manager, Global Submission Services, RA Operations

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
Ridgefield
10.2013 - 08.2014
  • Ensured timely preparation of component documents and assembly of applications to regulatory agencies, including Original INDs/NDAs/BLAs/MAAs/DMFs and life-cycle management.
  • Served as main point of contact with IT to ensure ongoing support to regulatory systems.
  • Acted as System Owner, Test Administrator, System Administrator and Subject Matter Expert.
  • Led a project and implemented departmental processes for creating and storing regulatory documents in new Electronic Document Management system (eDMS).
  • Provided expertise with system requirements gathering (i.e. attribute mapping and data migration) in accordance with regulatory needs and trained approximately 100 employees.
  • Defined strategies for ensuring documents required by regulators were compliant with FDA, ICH and CDISC guidelines and corporate policies.
  • Ensured timely implementation of electronic systems (e-review, report and dossier publishing, validation, electronics submissions gateway).
  • Key User, Global Business Administrator and Certified trainer.
  • Led and contributed to local and global working groups to define / refine / harmonize business processes per newly established Regulatory Operations structure.
  • Participated in industry review of ICH eCTD 4 (RPS) Implementation Guide and actively planned how to prepare for the conversion from eCTD v3.2.2 to 4.

Project Manager, RA Operations, eSubmissions Group

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
Ridgefield
08.2011 - 10.2013
  • Researched, developed, implemented and maintained current and long-term strategy, processes, training and technical support for electronic submissions to regulatory agencies, including hybrid CTD and eCTD.
  • Provided leadership and direction to senior management and project teams on local and global requirements.
  • Liaised with IT, other departments and external vendors to test and develop validation strategies for submission-related software.
  • Led validation-testing activities within regulatory operations for implementation of eCTD software acting as Test, Administrator, Key User and Business Administrator.
  • Led the implementation of BI’s Electronic Submissions Gateway software (AS2).
  • Authored Project Plans, Test plans, User Requirements, Test Scripts, Risk Analysis, Change Controls, Training Plans/materials, and conducted training.
  • Collaborated with RA Operations, Product Groups, and CMC RA groups, BI Canada, and BI Roxane Laboratories to establish efficient, high quality submission publishing methods by evaluating existing systems and processes and delivering solutions for new processes.
  • Led migration of BI’s eCTD applications into new eCTD tool; developed migration processes.
  • Implemented digital signatures for eCTDs, promotional material, and internal submission approval processes.

Technical Publishing Specialist III, RA Operations, Publishing Group

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
Ridgefield
05.2006 - 08.2011
  • Provided technical support for document publishing software.
  • Provided training to RA staff on publishing and eCTD software.
  • Liaison between IT and vendors to resolve technical issues for end users, updated processes to support use of software, and performed validation testing for the system implementation.
  • Established processes for report and dossier publishing using various tools (i.e. Lorenz Validator, Adobe Acrobat, ISIToolBox, remote data transfer, and FDA electronic submissions gateway).
  • Planned, assembled, published and dispatched submissions to health authorities (Original NDAs, Original INDs, IND/NDA Annual Reports, Promotional Material, Major supplements, and routine submissions).
  • Co-lead the implementation of eCTD software and collaborated in authoring Risk Analysis and User Requirements and PQ/OQ tests scripts.
  • Conducted validation testing.
  • Established business processes and quality checks for Biometrics and Data Management (BDM) group on the efficient delivery of submission relevant documents (Datasets, Case Report Forms, and Narratives).
  • Coordinated the timely authoring of eSubmission Proposals for Original NDAs in eCTD format following FDA, ICH and CDISC standards.

Publishing Technician II, RA Operations, Publishing Group

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
Ridgefield
04.2004 - 05.2006
  • Published documents in support of study reports and regulatory submissions including the creation of document and dossier templates.
  • Assembled and published Clinical Trial Reports, Clinical Summary Documents and Nonclinical reports.
  • Proofread and formatted regulatory documents and ensured eReadiness.

Document Technician, RA Operations, Archiving Group

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
Ridgefield
06.2002 - 04.2004
  • Responsible for information storage and retrieval of Clinical, Nonclinical, CMC, regulatory correspondence.

Education

Bachelors of Science - Technical Management

DeVry University
New Brunkswick, NJ
06.2008

Skills

  • Microsoft Office 365 applications
  • Word processing
  • Presentation software
  • Spreadsheet management
  • Project management tools
  • Email communication
  • Document collaboration
  • PDF editing
  • Regulatory submission tools
  • Publishing software
  • Quality management systems
  • Video conferencing solutions
  • Team collaboration platforms
  • Quality control
  • System implementation
  • Technical support
  • Performance evaluation
  • Document management
  • Submission management
  • Regulatory compliance
  • Process improvement
  • Training development
  • Electronic submission
  • Project management
  • Cross-functional communication
  • Adaptability
  • Problem resolution
  • Plan projects

Certification

  • Certified as Advanced Publisher (EZSubs Software)
  • ISIToolBox Pharma Certified
  • Veeva Vault Platform Business Administrator Certified, 2021
  • Veeva Vault Platform System Administrator, 2023
  • Veeva Vault Submissions Platform Business Administrator Certified, 2022
  • Veeva Vault Submissions System Administrator, 2023

Accomplishments

Diversity & Inclusion Champion Award sponsored by Boehringer Ingelheim, 2006, 2007

United States Achievement Academy -2000 National Awards for Environmental Chemistry and Science

Languages

English
Professional
Spanish
Professional
Portuguese
Elementary

References

References available upon request.

Timeline

Sr. Manager, Regulatory Systems Business Support, Regulatory Operations

CRISPR Therapeutics Inc.
12.2020 - 03.2025

Senior Manager of Regulatory Operations

TARGET HEALTH LLC
04.2017 - 12.2020

Associate Director, Regulatory Operations

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
08.2014 - 11.2016

Manager, Global Submission Services, RA Operations

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
10.2013 - 08.2014

Project Manager, RA Operations, eSubmissions Group

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
08.2011 - 10.2013

Technical Publishing Specialist III, RA Operations, Publishing Group

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
05.2006 - 08.2011

Publishing Technician II, RA Operations, Publishing Group

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
04.2004 - 05.2006

Document Technician, RA Operations, Archiving Group

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
06.2002 - 04.2004

Bachelors of Science - Technical Management

DeVry University

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