Justin Sims Plyler

About Justin Sims Plyler

Regulatory Operations professional with extensive experience managing, publishing, and supporting regulatory submissions to US, Canadian, EU, and other international Regulatory Agencies. Lead publishing and document compliance groups, ensuring proper quality, timely preparation, review, transmission and archival of all regulatory submissions. Collaborate with numerous teams to plan and provide guidance on all aspects of submission standards. Champion continuous improvement to incorporate lessons from submission experiences. Highly competent with desktop applications, submission publishing software, EDMS, and more with expertise in DocuBridge, Microsoft Office products, Adobe Acrobat, Veeva Vault, eCTD viewer, ISI ToolBox and others.

Experience

1. Senior Manager

   Emergent BioSolutions

   Feb 2024 — Present · Gaithersburg, MD, US

   Lead RO publishers and formatters, ensuring all Regulatory submissions are planned, prepared, published, and submitted to FDA, HC, EMA, Singapore, TGA, and other regulatory authorities. Train and support users in submission publishing standards, Lorenz Docubridge publishing tool, and Veeva EDMS. Provide guidance to RA teams related to U.S. and international publishing requirements. Supervise Regulatory Operations formatters to ensure specialists are managing requests effectively and all regulatory submission documents (Word and PDF) comply with company standards. Provide individual and group training on use of authoring templates and Emergent formatting standards. Responsible for maintenance of submission templates and formatting standards, working with RA to update content and improve user experience. Facilitate continuous improvement with team, emphasizing the power of every team member learning from each experience, sharing lessons, and consolidating them into department policies/practices. This led to development of numerous work instructions and a continuously updated Regulatory knowledge base, training videos, and other tools that provide step-based instructions for submission preparation and review.

Education

• Darla Moore School of Business at the University of South Carolina

  B.S., Management and Marketing

  1991 — 1995