Summary
Overview
Work History
Education
Skills
Timeline
Generic

Betty Jager

Clemmons,NC

Summary

Regulatory professional with extensive experience in project management and quality control at British American Tobacco. Led e-submission initiatives that achieved significant cost savings and ensured timely delivery of complex submissions. Demonstrated expertise in navigating veterinary health regulations with a strong focus on detail and adaptability in dynamic environments.

Overview

13
13
years of professional experience

Work History

Lead Submissions Specialist, E-Submissions Scientific, and Regulatory Affairs

British American Tobacco (Reynolds American)
Winston-Salem, North Carolina
09.2018 - 04.2025
  • Achieved electronic submission of first PMTA at Reynolds American, streamlining compliance processes.
  • Coordinated 250-member project team to deliver over 400,000 pages of regulatory documentation.
  • Implemented e-submitter processes for Premarket Tobacco Product Applications within FDA guidelines.
  • Trained regulatory team on E-Submitter Software, enhancing submission efficiency.
  • Established access to SharePoint libraries to improve collaboration and support initiatives.
  • Reduced vendor fees by over $100,000 through efficient in-house e-submission practices.
  • Guided file review processes, completing projects seven months ahead of schedule.
  • Submitted regulatory documentation for leading global tobacco brands, including Dunhill and Lucky Strike.

Manager, Submission Publishing

Zoetis Inc. (Previously Pfizer Animal Health)
Kalamazoo, Michigan
02.2012 - 08.2018
  • Transitioned traditional paper submissions to electronic standards over two decades.
  • Served as primary publisher for United States submissions to CVM and USDA for Zoetis products.
  • Led implementation of E-submitter tool, acting as subject matter expert and system owner.
  • Promoted to Submission Publishing Manager post-merger, managing team of regulatory publishers.
  • Coordinated transition from legacy processes to electronic submissions, training project teams on new procedures.
  • Oversaw submission scheduling and project tracking to ensure compliance with timelines.
  • Provided testing support and insights for Veeva Vault selection as document management system.
  • Coordinated project timelines with cross-functional teams for timely completion.
  • Provided leadership during times of organizational change or crisis situations.

Education

Bachelor of Science (B.S) - Public Policy and Government

Eastern Connecticut State University
Willimantic, Connecticut

Skills

  • Attention to detail
  • Veterinary health regulations
  • Quality control and auditing
  • Data entry and recordkeeping
  • Continuous improvement
  • Project management
  • Adaptability to change
  • Organizational skills
  • Work prioritization
  • E-submitter processes

Timeline

Lead Submissions Specialist, E-Submissions Scientific, and Regulatory Affairs

British American Tobacco (Reynolds American)
09.2018 - 04.2025

Manager, Submission Publishing

Zoetis Inc. (Previously Pfizer Animal Health)
02.2012 - 08.2018

Bachelor of Science (B.S) - Public Policy and Government

Eastern Connecticut State University
Betty Jager
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