PETER OH
Everett,WA
Summary
Detail-oriented Senior Associate with over 5 years in global regulatory submissions within biotechnology. Skilled in preparing and publishing INDs, NDAs, and MAAs for US, EU, and APAC health authorities. Experienced with Veeva RIM Vault, Adobe Acrobat Pro, and eCTD/NeeS compilation, consistently delivering submission-ready packages that achieve zero technical rejections.
Overview
13
13
years of professional experience
Work History
Senior Associate, Regulatory Submissions Operations
BeOne Medicines
03.2026 - 10.2026
- Serve as the primary operational strategist for complex lifecycle maintenance submissions, ensuring consistent, high-quality deliverables across a high-volume portfolio.
- Mentored junior associates on document styling, template standards, and formatting best practices to enhance submission preparation efficiency.
- Generate precise PDF bookmarks, internal cross-reference hyperlinks, and optimized file outputs using advanced PDF functionality, ensuring seamless navigation and reviewer accessibility for all major global submissions.
- Served as primary operational strategist for complex lifecycle maintenance submissions, delivering consistent, high-quality outcomes across high-volume portfolio.
- (formerly BeiGene)
Associate, Regulatory Submissions Operations
BeiGene
07.2021 - 02.2026
- Maintained a fully compliant, audit-ready Regulatory Archive system, managing all Health Authority correspondence and submission documentation.
- Acted as the central point of contact for regulatory information requests, delivering accurate metrics and historical data to internal stakeholders across Drug Safety, Legal, and Program Management.
- Led large-scale data cleanup initiatives, standardizing legacy records and generating ad-hoc reports that streamlined operational workflows.
- Formatted Word documents by creating bookmarks, links, and applying headers/footers, ensuring all source documents were submission-ready prior to publishing.
- (now BeOne Medicines)
Assistant Property Manager
Tandem Property Management
01.2016 - 01.2021
- Managed operations for 600+ tenants across 406 units, ensuring regulatory compliance and effective project management.
- Resolved complex tenant issues while maintaining thorough documentation to support property management processes.
- Set up remote work systems and provided technical support to facilitate seamless operations for teammates during COVID-19 lockdown.
Member Services Representative
YMCA of Snohomish County
01.2014 - 01.2016
- Maintained accurate client records and resolved customer concerns to enhance client satisfaction.
- Welcomed members, answered inquiries, and delivered courteous front-desk service.
- Processed memberships, program registrations, and payments with accuracy.
- Resolved member concerns, escalating issues when needed to support satisfaction.
Education
Associate of Science - Computer Science
Everett Community College
Everett, WA01-2018
No Degree - Computer Science
Biola University
Los Angeles, CA01-2012
Skills
- Submissions management
- eCTD publishing
- Regulatory Operations & Publishing
- CTD structure knowledge
- Veeva document management
- Advanced PDF formatting
- Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
- MS Word Templates & styles management
- Regulatory Data Analysis
- Lorenz
- Cross-functional collaboration
- Veeva Vault
- Attention to detail
Timeline
Senior Associate, Regulatory Submissions Operations
BeOne Medicines
03.2026 - 10.2026
Associate, Regulatory Submissions Operations
BeiGene
07.2021 - 02.2026
Assistant Property Manager
Tandem Property Management
01.2016 - 01.2021
Member Services Representative
YMCA of Snohomish County
01.2014 - 01.2016
No Degree - Computer Science
Biola University
Associate of Science - Computer Science
Everett Community College