Regulatory Affairs Manager

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Job Title: PRC Submission Management Lead

Duration: 06 Months

Location:
Foster City, CA 94404 (Hybrid)

Description:

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:

• 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.

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 Promo Mats

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

Unique Selling Point of this role:

a. The position is ideal for someone who wants to influence enterprise-level change, contribute to next-generation regulatory solutions, and work in a high-impact, cross-functional environment that values both subject matter expertise and operational agility.

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

• Seniority level Associate

• Employment type
  
  Contract

• Job function Science
• Industries Medical Equipment Manufacturing

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