What are the responsibilities and job description for the Regulatory Affairs Manager (Labeling) position at Cube Hub Inc.?
Job Title: Commercial Labeling Project Management Contractor
Location (Hybrid/Onsite – within 50 miles of one of the following):
- Thousand Oaks, CA (Preferred)
- El Segundo, CA
- Frederick, MD
- Oceanside, CA
- Foster City, CA
Duration: 17-Month Contract
Job Summary
We are seeking a Commercial Labeling Project Management Contractor to support commercial labeling operations in a regulated pharmaceutical/biotech environment. This role is responsible for managing end-to-end labeling workflows, artwork review cycles, documentation, and cross-functional coordination to ensure compliant and timely delivery of labeling updates.
Key Responsibilities
- Manage end-to-end commercial labeling workflows and approvals using Veeva Vault or similar systems.
- Coordinate artwork development, proof reviews, comment resolution, and final approvals.
- Track project timelines, milestones, and deliverables across multiple labeling initiatives.
- Partner with print vendors to manage artwork proofs and revisions.
- Perform proofreading and quality checks using Adobe Acrobat and GlobalVision.
- Support labeling changes, obsolescence tracking, and phase-in/phase-out activities.
- Maintain compliant documentation following Good Documentation Practices (GDP).
- Collaborate with Regulatory, Quality, Supply Chain, and global stakeholders.
- Identify project risks, escalate issues, and provide regular status updates.
Required Qualifications
- 3–5 years of experience in pharmaceutical/biotech labeling, regulatory operations, or supply chain.
- Experience managing commercial labeling workflows and artwork approval processes.
- Hands-on experience with Veeva Vault or similar document management systems.
- Experience using Adobe Acrobat and proofreading tools such as GlobalVision.
- Strong project management and organizational skills.
- Experience working in a GxP-regulated environment.
- Excellent communication and attention to detail.
Preferred Qualifications
- Experience with global labeling requirements.
- Experience working with print vendors and packaging components.
- Familiarity with Adobe Creative Suite and BarTender.
Salary : $55 - $60