Location: Onsite - Thousand Oaks, CA

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 12 months (possible extension)

Compensation: $21/$24 per hour (based on experience)

Summary of the Role

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.

Key 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

Required Experience & Skills

• 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

Preferred Qualifications

• 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

Top 3 Must Have Skills

1. Expert knowledge of Veeva Vault RIM.

2. High level of digital literacy with various tools (e.g., Smartsheet, Miro, MS Copilot, ChatGPT Enterprise, Tableau).

3. Ability to handle multiple tasks and deadlines in a fast-paced environment.

Day-to-Day Responsibilities

• 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

Basic Qualifications

• 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

This posting is for Contingent Worker, not an FTE