Job Description

Responsibilities:

• Excellent employment opportunity for a Regulatory Affairs Manager in the Foster City, CA area. Hybrid
• PRC Submission Management Lea
• 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.
• 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 Gilead’s AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.

Experience:

• Required Years of Experience: 6-8 years
• 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.
• Top 3 Required Skill Sets:
• Experience in Medical, Legal, and Regulatory (MLR) review process
• Proficiency in Veeva Vault PromoMats
• Project Management and workflow optimization
• Top 3 Nice to Have Skill Sets:
• Documentation and process mindset
• Change Management
• Familiarity with AI
• 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

Job Tags

Similar Jobs