New 
PRC Submission Management Lead
 Spectraforce Technologies | |
 United States, California, Foster City | |
 Oct 13, 2025 | |
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Job Title: PRC Submission Management Lead
Location: Foster City, CA (94404) - Hybrid Duration: 5 months Description: We are seeking a seasoned PRC Submission Management Lead to support the CPC team. This specialized role requires deep expertise in the Medical, Legal, and Regulatory (MLR) review and approval process, with a strong operational focus. The ideal candidate will have hands-on experience managing digital submissions in Veeva Vault and be comfortable navigating the complexities of PRC workflows. 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, including coordinating re-review cycles and working closely 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 its 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 Top 3 Required Skill Sets: a. Experience in Medical, Legal, and Regulatory (MLR) review process b. Proficiency in Veeva Vault PromoMats c. Project Management and workflow optimization Top 3 Nice to Have Skill Sets: a. Documentation and process mindset b. Change Management c. Familiarity with AI Unique Selling Point of this role: a. The position is ideal for someone who wants to influence enterprise-level change, contribute to next-generation regulatory solutions, and work in a high-impact, cross-functional environment that values both subject matter expertise and operational agility. Required Degree or Certification * Veeva Vault Certification or Training - demonstrating proficiency in the platform * Project Management Certification (e.g., PMP) - helpful for managing review cycles and cross-functional coordination | |