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Lateral thinker with 15 years experience in drug and device pharmaceutical Regulatory Labeling, DSCSA and UDI. Possesses the ability to work proactively in a fast paced environment, eager to learn new skills and thrives under pressure. Strong medical regulatory guidance interpretation abilities. Detail oriented, dependable and self motivated individual, capable of prioritizing and multi tasking. Has good organizational, time management, communication and people skills and enjoys working as a team member, and great interpersonal skills. Fluent in Spanish. In search of a challenging position with a progressive, growth-oriented company offering the opportunity for personal growth and advancement. Willing to relocate and travel.

Work History


Regulatory Manager | Labeling | DSCSA

Sagent Pharmaceuticals

Manage workflow of the labeling department. Set daily priorities and timelines. Work with upper and project management to establish timelines to meet patent expiry, support drug shortages, responses to deficiencies, post-market and regulatory submissions.

Final review and approval of submission, deficiency response, initial launch, RLD updates and post-approval labeling packages. 

A lead team member to assist in the companies implementation of the 2017 Track and Trace serialization (DSCSA) initiative. Understanding the laws published by Congress and FDA leading the preparation with company, partner, label and software readiness. Serving as main contact for regulatory interpretation and label updates not limited to regulatory, tooling and data/validation requirements.

Developed labeling projects with 20+ domestic and foreign partners including new ANDA development, third party labeling, joint ventures and private labeling (Novation, Premier, AmerisourceBergen). Includes the request and review of dyelines, barcode creation, and the request and review of all label claims and other forms from all partners. 

Practical and working knowledge of drug listing, metadata reviews, submission SPLs, and establishment registrations.

Process owner of establishing new NDC numbers.

Full ownership and responsibility of the monitoring and communication of design label updates to those inside and outside of the organization. Ensure timely implementation of updated labeling components.

Apr 20132016

Sr Associate Regulatory Affairs Labeling

Sagent Pharmaceuticals

Responsible for supporting the Labeling Team in all aspects of label development (including labeling for regulatory submissions and commercial products) to ensure accuracy related to current text copy and marketing selected design elements. Includes development, editing, and critical review of label copy, support managers in the maintenance of labeling regulatory / quality systems, and updating and managing SPL files. Execute activities revolving around shifting labeling priorities including label copy development, proofreading and updating based on partner or FDA requests in an accurately and timely manner. Prepare and critically review labeling files for labeling at all stages of the development life cycle (including submission, deficiency, launch and commercially available labeling) and understanding unique requirements at each phase. Interface with CMO’s and internal stakeholders to create and update label copy for FDA submissions or to respond to deficiencies or RLD updates.

Key Accomplishments

  • Lead Label Designer and design project manager. Including creation, updates and agency written responses.
  • Proofing software validation and written procedures.
  • Barcode software validation and written procedures.
  • DSCSA implementation team member. UDI implementation to device labeling.
Nov 2006Apr 2013

Device Label Editor

Hospira, Inc.

Responsible for compliant change control of documentation and labeling including new and revised policies, procedures, specifications and domestic labeling artwork for Hospira, outside contract and third party manufactured product. Responsibility includes day to day authority to develop, annotate, format, review and approve documentation and labeling. Timely approval and release of specifications and labeling in accordance with project milestones and customer requirements. 2012 high performer rating.

Major duties and responsibilities include:

  • Perform activities related to creation of new and revisions to existing product family labeling, manufacturing specifications, test methods and corporate policies and procedures. As well as abiding by change control processes to ensure that revisions made are in compliance with domestic regulatory regulations, business and customer expectations.
  • Project manage decision tree for consumable products for change management process. Push change management form to completion collaborating with functional areas for approval.
  • Resolve daily issues inherent to domestic product documentation and labeling.
  • Served as the primary contact for day to day customer inquires.
  • Demostrate financial fitness of documentation and labeling changes to minimize potential destruction. Worked with the manufacturing plants and materials management formulating an implemenation plan.
  • Manage multiple assignments and meet all required timelines.
  • Analytical skills to gather facts and data, determine the options, analyze the risks (e.g. safety, cost, sales, etc.), and select the best option. Analyze and interpret labeling.
  • Graphic Label Design using InDesign software.
Feb 2004Nov 2006

Sr. Specification Technician

Hospira, Inc.

Authoring and handling Change Control documentation electronically pertaining to internal specifications (drawing changes, obsolete documents, etc.), in compliance with cGMPs. Responsible for updating plant and vendor controlled documents in Documentum based on input from editors and engineers. Designed and maintained trending metrics/reports. Interacting with production planning and plant operations to ensure timely implementation of controlled specifications. Training new hires on Specification Technician duties. Interfacing with IT on system failures. Authored, revised, proofread and distributed internal specifications to manufacturing sites. Create Redlines in Adobe of Specifications. Perform extensive searches for commodity numbers and list numbers for Drawing Changes and List Deactivations. A Documentum Admin and Publisher for department webpage.

Key Accomplishments

  • Labeling representative on Standards project team to standardize documents for consistency and improve current processes to optimize efficiencies.
  • Management and distribution of all labeling specification task throughout the department.
  • Tracked progress of electronic Change requests for internal documents during routing to sites for approval in order to expedite change implementation and to pinpoint workflow bottlenecks.
  • Apply Value Stream Mapping and Project Fuel to processes in Label Control Deparment.
  • Created new List Deactivation process. Communicated with multiple groups and sites to develop a module that would interact with Centralized Materials Management Group.
  • Assisted in creation of process maps of each work flow within the department.
  • Formed multiple search criteria for system requirements in order to stay in compliance.
Jun 2001Jan 2004


Abbott Laboratories
  • Prepared validation documentation for the roll out of a Laboratory Information Management System (LIMS). Documentation included Requirement, Design Specification and Test Plans.


Aug 1999May 2001


College of Lake County

Applied Science in Computer Information Systems/PC LAN Support Specialist

Certificate in Computer Information Systems Network Specialist

Aug 1999May 2001


College of Lake County

Applied Science in Computer Information Systems/Microcomputer Applications

Certificate in Microcomputers for Business


Jun 2001Aug 2001

21 CFR Part 11

Aug 1999May 2001

Computer Information Systems Network

Aug 1999May 2001


For Business