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