Summary
Overview
Work History
Education
Skills
Affiliations and Training
Certification
References
Timeline
Generic

Christopher Plescia

Round Lake,IL

Summary

Regulatory affairs professional with extensive experience at Baxter Healthcare Corporation, showcasing expertise in global submission strategies and compliance. Excelled in project management and RIM systems, leading to streamlined electronic submissions and enhanced operational efficiencies. Proven track record in training development and process optimization, demonstrating exceptional leadership and technical skills.

Overview

16
16
years of professional experience
1
1
Certification

Work History

Manager, Global Regulatory Affairs

Baxter Healthcare Corporation
Round Lake, IL
07.2019 - Current
  • Partner with submission owners, project teams, authoring support, and publishing to plan, support, and provide tactical guidance on submission activities, while proactively identifying, managing, and communicating risks and issues to ensure high quality, on-time submissions.
  • Manage the regulatory document planning and submission process for major projects throughout the product lifecycle to ensure documents meet applicable regulatory requirements.
  • Manage and track submission progress against milestone targets to proactively identify risks to submission timelines, along with resolutions.
  • Subject matter expert and core member of the RIM Center of Excellence for the Veeva Vault RIM system.
  • Work with project teams to coordinate applicable system training needed to complete submission activities.
  • Support the development and execution of standardized processes for global electronic submissions.
  • Training support representative for the Regulatory Affairs team.

Specialist, Regulatory Affairs Operations

Baxter Healthcare Corporation
Round Lake, IL
12.2013 - 07.2019
  • Coordinated annual compliance submissions to the FDA for A/NDA, BLA, DMF, and IND applications.
  • Developed and presented training modules on the U.S. annual report process to Regulatory colleagues and contributing functional partners.
  • Subject matter expert for RIM systems and U.S. annual report processes.
  • Provided RIM systems, process support, and guidance to Regulatory colleagues.
  • Managed the project to convert dossiers to eCTD format for approved products in the EMEA region.
  • Led or participated in sub-teams to identify and carry out the optimization of internal regulatory processes.
  • Led a project to optimize the use of FDA Form 356h to improve work efficiencies.

Associate, Regulatory Affairs - Post-Market Drugs

Baxter Healthcare Corporation
Round Lake, IL
06.2011 - 12.2013
  • Regulatory representative on project teams for responsible products.
  • Owned CMC content for assigned U.S. drug applications and Drug Master Files.
  • Global lead for regulatory change control assessments and supported colleagues with regulatory filings outside the U.S.
  • Performed the U.S. regulatory assessments and submissions to FDA for change controls.
  • Provided training on change control and annual report processes for new colleagues.

Associate, RA Submissions Management

Baxter Healthcare Corporation
Round Lake, IL
01.2011 - 05.2011
  • Coordinated and assembled regulatory submissions and documentation packages.
  • Published regulatory submissions using electronic publishing systems.
  • Assisted with the definition of electronic document management, submission publishing processes, and standard operating procedures.

Associate, Regulatory Affairs - US Compliance

Baxter Healthcare Corporation
Round Lake, IL
03.2009 - 12.2010
  • Managed over 600 controlled substance, manufacturer, pharmacy, and wholesale distributor state licenses required to ensure products were manufactured and distributed in compliance with US state regulations.
  • Eliminated unnecessary state licenses, resulting in an approximate cost reduction of $24,000.
  • Created a centralized hub for distribution centers and manufacturing plants to simplify licensing maintenance, and communication.

Education

M.S. - Biotechnology

Northwestern University
Evanston, IL

B.S. - Clinical Laboratory Science

Eastern Illinois University
Charleston, IL

Skills

  • Project management
  • Regulatory compliance
  • Process improvement
  • Veeva Vault RIM
  • DXC FirstDoc
  • DXC eCTDXPress Viewer
  • ISIWriter
  • Microsoft Office
  • Microsoft Project

Affiliations and Training

  • Regulatory Affairs Certification (US)
  • Medical Technologist Certification, Board of Registry, American Society for Clinical Pathology
  • Lead the Way - Leadership Training Seminar

Certification

  • Regulatory Affairs Certification (RAC-US), issued 2018

References

References available upon request.

Timeline

Manager, Global Regulatory Affairs

Baxter Healthcare Corporation
07.2019 - Current

Specialist, Regulatory Affairs Operations

Baxter Healthcare Corporation
12.2013 - 07.2019

Associate, Regulatory Affairs - Post-Market Drugs

Baxter Healthcare Corporation
06.2011 - 12.2013

Associate, RA Submissions Management

Baxter Healthcare Corporation
01.2011 - 05.2011

Associate, Regulatory Affairs - US Compliance

Baxter Healthcare Corporation
03.2009 - 12.2010

M.S. - Biotechnology

Northwestern University

B.S. - Clinical Laboratory Science

Eastern Illinois University

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