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Regulatory Affairs Manager - Advertising and Promo Job at Fladger Associates in
Regulatory Affairs Manager - Advertising and Promo Job at Fladger Associates inMediabistro • Foster City, CA, United States
Regulatory Affairs Manager - Advertising and Promo Job at Fladger Associates in

Regulatory Affairs Manager - Advertising and Promo Job at Fladger Associates in

Mediabistro • Foster City, CA, United States
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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
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    Manager Advertising • Foster City, CA, United States

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