Regulatory Affairs Manager

Our direct BioPharmaceutical client is looking to hire a Regulatory Affairs Manager - Foster City, CA (Hybrid).

Duration: 6 to 12 months contract (possible even further extension).

Location: Foster City, CA (Hybrid - 2 days Remote and 3 days onsite).

Description:

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.

Top 3 Required Skill Sets:

1. Experience in Medical, Legal, and Regulatory (MLR) review process.
2. Proficiency in Veeva Vault PromoMats.
3. Project Management and workflow optimization.

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 (Promotional Review Committee) 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 Client's 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.