Admin Coordinator
Advanced Bio-Logic Solutions Corp•Thousand Oaks, CA
1d•$21 - $24•Onsite
About The Position
Join a leading biopharma organization to support onsite administrative operations and drive critical regulatory and project initiatives. This role manages the end-to-end FDA Certificate of Pharmaceutical Product (CPP) process and supports document authentication, dispatch, and archiving. The successful candidate will collaborate with cross-functional teams to ensure regulatory compliance and efficient documentation workflows.
Requirements
- Demonstrated ability to coordinate projects and processes with cross-functional teams
- Excellent organizational, communication, and multitasking skills
- Proficiency with digital workflow and documentation platforms (e.g., Smartsheet, SharePoint, Microsoft Teams)
- Familiarity with regulatory document management and submission processes
- Ability to work onsite 1–2 days per week and meet regulatory deadlines
- Expert knowledge of Veeva Vault RIM.
- High level of digital literacy with various tools (e.g., Smartsheet, Miro, MS Copilot, ChatGPT Enterprise, Tableau).
- Ability to handle multiple tasks and deadlines in a fast-paced environment.
- Associate degree and 2 years of experience
- 2 years in a technical school setting with hands-on experience
- High school diploma / GED and 4 years of experience
Nice To Haves
- Proven experience driving process improvements
- Expert knowledge of Veeva Vault RIM
- Advanced digital literacy with tools such as Smartsheet, Miro, MS Copilot, ChatGPT Enterprise, and Tableau
- Strong interpersonal skills for stakeholder engagement
- Ability to adapt to new digital tools and fast-paced environments
Responsibilities
- Manage the complete US FDA Certificate of Pharmaceutical Product (CPP) process from application drafting to international delivery
- Serve as the main liaison between the FDA and internal stakeholders for issue resolution and document updates
- Initiate and manage the authentication process for CPPs through the US State Department, Embassies, and Chambers of Commerce
- Track and oversee CPP applications throughout all process lifecycle stages
- Support the State Licensing team by monitoring the physical mailbox, scanning documents, and handling shipments
- Manage authentication processes for country-specific documents across all products, sites, and development phases
- Obtain and coordinate document authentications and timely dispatch to relevant end users
- Archive documents per regulatory requirements and established procedures
- Maintain and update authentication process documentation; train CMC staff on workflows
- Assist Regulatory teams with compendial monograph management and provide analytical support for special projects
- Manage the FDA Certificate of Pharmaceutical Product (CPP) process from application to delivery
- Liaise with the FDA and internal teams for issue resolution and document updates
- Handle authentication and dispatch of CPPs and country-specific documents
- Monitor the ATO mailbox and coordinate physical documentation shipments
- Support CMC staff and Regulatory teams with document management, training, and special projects
- Leverage digital tools to automate workflows and maintain documentation
- Provide FDA forms to necessary stakeholders and maintain process documentation
- Work onsite regularly to coordinate notarizations, signatures, and compliance tasks
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What This Job Offers
Career Level
Entry Level
Education Level
Associate degree
