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, ConnecticutSkills
- 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