Cube Hub Inc.
Overview
Job title: Regulatory Affairs Manager/PRC Submission Management Lead Job Poster: Cube Hub Inc. Job Location: Foster City, California (Onsite) Job Duration: 6 months Base pay range: $75.00/hr - $85.00/hr This role requires deep expertise in the Medical, Legal, and Regulatory (MLR) review and approval process, with a strong operational focus. The candidate should have hands-on experience managing digital submissions in Veeva Vault and be comfortable navigating PRC workflows. This position supports the CPC team and will involve collaboration with cross-functional groups including Gilead’s AI team on regulatory considerations for AI-enabled content creation and regulatory fact-checking. __________________________________________________
Key Responsibilities
Serve as a Subject Matter Expert (SME) in US CPC team, ensuring compliance with regulatory standards and internal processes. Manage end-to-end MLR review cycles, including submission preparation, routing, and tracking through Veeva Vault. Attend PRC meetings to represent submission status, clarify content, and capture feedback. Triaging and managing review comments from MLR teams, coordinating re-review cycles, and working with agencies or the Content Production Center (CPC) to ensure timely closure. Conduct reference checks prior to PRC submission/routing to ensure accuracy and completeness. Provide training and guidance to CPC team members on regulatory guidelines and best practices. Develop a playbook outlining optimal ways of working across PRC and CPC teams. Collaborate with Gilead’s AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.
Qualifications
Proven experience in US Commercial Regulatory Affairs, specifically within PRC/MLR review operations. Strong working knowledge of Veeva Vault, including digital asset submission, routing, and tracking. Demonstrated ability to manage complex review cycles and collaborate across cross-functional teams. Experience working with agencies and internal content teams to resolve feedback and ensure compliance. Operational mindset with the ability to streamline processes, identify gaps, and implement best practices. Prior experience in training and documentation development is a plus. Familiarity with AI applications in regulatory or marketing contexts is a bonus. Required Years of Experience: 6-8 years Required Degree or Certification: Veeva Vault Certification or Training; Project Management Certification (e.g., PMP) is helpful
Skills & Certifications
MLR review process Veeva Vault PromoMats Project management and workflow optimization
Note: This description retains the core responsibilities, qualifications, and context of the role while removing extraneous boilerplate and inconsistent formatting present in the original text.
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Job title: Regulatory Affairs Manager/PRC Submission Management Lead Job Poster: Cube Hub Inc. Job Location: Foster City, California (Onsite) Job Duration: 6 months Base pay range: $75.00/hr - $85.00/hr This role requires deep expertise in the Medical, Legal, and Regulatory (MLR) review and approval process, with a strong operational focus. The candidate should have hands-on experience managing digital submissions in Veeva Vault and be comfortable navigating PRC workflows. This position supports the CPC team and will involve collaboration with cross-functional groups including Gilead’s AI team on regulatory considerations for AI-enabled content creation and regulatory fact-checking. __________________________________________________
Key Responsibilities
Serve as a Subject Matter Expert (SME) in US CPC team, ensuring compliance with regulatory standards and internal processes. Manage end-to-end MLR review cycles, including submission preparation, routing, and tracking through Veeva Vault. Attend PRC meetings to represent submission status, clarify content, and capture feedback. Triaging and managing review comments from MLR teams, coordinating re-review cycles, and working with agencies or the Content Production Center (CPC) to ensure timely closure. Conduct reference checks prior to PRC submission/routing to ensure accuracy and completeness. Provide training and guidance to CPC team members on regulatory guidelines and best practices. Develop a playbook outlining optimal ways of working across PRC and CPC teams. Collaborate with Gilead’s AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.
Qualifications
Proven experience in US Commercial Regulatory Affairs, specifically within PRC/MLR review operations. Strong working knowledge of Veeva Vault, including digital asset submission, routing, and tracking. Demonstrated ability to manage complex review cycles and collaborate across cross-functional teams. Experience working with agencies and internal content teams to resolve feedback and ensure compliance. Operational mindset with the ability to streamline processes, identify gaps, and implement best practices. Prior experience in training and documentation development is a plus. Familiarity with AI applications in regulatory or marketing contexts is a bonus. Required Years of Experience: 6-8 years Required Degree or Certification: Veeva Vault Certification or Training; Project Management Certification (e.g., PMP) is helpful
Skills & Certifications
MLR review process Veeva Vault PromoMats Project management and workflow optimization
Note: This description retains the core responsibilities, qualifications, and context of the role while removing extraneous boilerplate and inconsistent formatting present in the original text.
#J-18808-Ljbffr