Regulatory Ops Manager I - Submissions & EDMS

Tarsus Pharmaceuticals, Inc.; California (MO); Hybrid; USD 98,000 - 137,000; Full time

Job summary

Tarsus Pharmaceuticals, Inc. is seeking a Manager I, Regulatory Affairs Operations to support electronic submission management and dossier lifecycle activities from Irvine, CA.

The role emphasizes content planning within Veeva Vault RIM, collaboration with publishing vendors, and ensuring alignment with FDA/EMA guidelines. The ideal candidate has 5+ years in Regulatory Affairs Operations focusing on publishing and submissions, with strong project management skills and the ability to meet firm

Qualifications

• Bachelor’s degree in science or health-related discipline.
• Minimum of 5+ years of Regulatory Affairs Operations experience with publishing/submissions management.
• Knowledge of FDA, EMA, ICH guidelines including eCTD.
• Experience with Veeva Vault RIM/Veeva RIMS administration.
• Ability to manage multiple projects and prioritize to deadlines.

Responsibilities

• Create and maintain content plans within Veeva Vault RIM and understand eCTD hierarchy.
• Assist with planning, archiving of submissions and dossier lifecycle management.
• Support submissions team with project management and tracking.
• Coordinate with external publishing vendors for submissions.
• Develop regulatory operations processes and help build a compliant team.
• Maintain training records and ensure required trainings are completed.

Skills

Regulatory affairs operations

Publishing

Submissions management

Project management

Communication

Collaboration

Education

Bachelor’s degree in science

Tools

Veeva Vault RIM

Veeva RIMS

eCTD templates

Microsoft Word

Microsoft Project

Excel

Job description

Tarsus Pharmaceuticals, Inc. is seeking a Manager I, Regulatory Affairs Operations to support electronic submission management and dossier lifecycle activities from Irvine, CA.

The role emphasizes content planning within Veeva Vault RIM, collaboration with publishing vendors, and ensuring alignment with FDA/EMA guidelines. The ideal candidate has 5+ years in Regulatory Affairs Operations focusing on publishing and submissions, with strong project management skills and the ability to meet firm