Regulatory Affairs Manager

Job Description

Job title : PRC Submission Management Lead

Location : Foster City, CA

Duration : 06+ Months

Client is 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 Gilead’s AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.

Qualifications

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