Regulatory Affairs Manager

Job description

4 days ago Be among the first 25 applicants

This range is provided by ACL Digital. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$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

Worksite address

foster city, CA, 94420, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.