ACL Digital
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$80.00/hr - $85.00/hr Direct message the job poster from ACL Digital 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 • 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 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 Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Research Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at ACL Digital by 2x Get notified about new Regulatory Affairs Manager jobs in
Foster City, CA . Quality Assurance & Regulatory Affairs Manager
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$80.00/hr - $85.00/hr Direct message the job poster from ACL Digital 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 • 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 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 Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Research Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at ACL Digital by 2x Get notified about new Regulatory Affairs Manager jobs in
Foster City, CA . Quality Assurance & Regulatory Affairs Manager
Redwood City, CA $124,000.00-$171,000.00 6 days ago Santa Clara, CA $129,000.00-$147,000.00 1 month ago San Francisco Bay Area $120,000.00-$160,000.00 3 weeks ago Pleasanton, CA $92,000.00-$124,340.00 2 weeks ago Menlo Park, CA $135,000.00-$150,000.00 3 weeks ago San Francisco, CA $100,000.00-$150,000.00 9 months ago San Francisco, CA $100,000.00-$150,000.00 8 months ago Regulatory Compliance & Technical Services Specialist,
South San Francisco, CA $75,000.00-$90,000.00 3 days ago Senior Regulatory Affairs Manager - Oncology
Associate Director/Director Regulatory Affairs
San Francisco Bay Area $190,000.00-$250,000.00 1 month ago Redwood City, CA $90,000.00-$120,000.00 3 weeks ago San Francisco Bay Area $180,000.00-$225,000.00 1 hour ago Sr Manager / Associate Director of Regulatory Affairs US Lead
Senior Regulatory Affairs Specialist – Vascular (on-site)
Regulatory Affairs Manager – Heart Failure (on-site)
Pleasanton, CA $112,000.00-$224,000.00 1 month ago Sr. Staff Technical Program Manager, R&D Regulatory Compliance
Mountain View, CA $166,000.00-$271,000.00 5 days ago Regulatory Affairs Manager – Vascular (on-site)
Santa Clara, CA $112,000.00-$224,000.00 2 months ago Program Manager, Regulatory Compliance - US Governance
San Francisco, CA $57.70-$72.60 2 weeks ago Regulatory Affairs Manager – APAC - Diabetes Care (on-site)
Alameda, CA $112,000.00-$224,000.00 2 months ago Manager, Regulatory Affairs - Shockwave Medical
Program Manager, Regulatory Compliance - US Governance
Mountain View, CA $57.70-$72.60 2 weeks ago Redwood City, CA $124,000.00-$171,000.00 4 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr