Regulatory Affairs Operations Manager I

Welcome to the Tarsanet Internal Career Center!; Irvine (CA); Hybrid; USD 81,900 - 136,500; Full time

Benefits offered by this job

Hybrid work environment

Onsite gym, pool and snacks

Catered meals occasionally

Comprehensive benefits

Job summary

Tarsus is seeking a Manager I, Regulatory Affairs Operations in Irvine, CA. You will manage electronic submission tools (Veeva Vault RIM) and drive the dossier lifecycle while aligning with FDA/EMA guidelines.

The role emphasizes planning, archiving, and coordinating cross‑functional teams to meet tight deadlines. You will lead content planning, support submissions, and help evolve regulatory operations processes.

Qualifications

• Bachelor’s degree in science or health-related discipline or equivalent experience.
• Minimum of 5+ years of Regulatory Affairs Operations experience focusing on publishing and submissions management.
• In-depth understanding of FDA/EMA/ICH guidelines and eCTD concepts (NDA/IND/MAA).
• Experience with Veeva Vault RIM (administrator experience preferred).
• Strong analytical skills and attention to detail.

Responsibilities

• Create and maintain content plans within Veeva Vault RIM and understand eCTD hierarchy.
• Plan, manage, and archive submissions and regulatory authority correspondence; ensure annual reporting compliance.
• Support RA submissions team with project management, tasks, and tracking.
• Coordinate regulatory submissions with external publishing vendors.
• Develop and improve RA operations processes and systems; manage team initiatives.

Skills

Regulatory operations

Project management

Attention to detail

Collaboration

Decision making

Independence

Education

Bachelor’s degree in science or health-related discipline

Tools

Veeva Vault RIM

Veeva RIMS

eCTD

eCTD templates

DXC Toolbox

MS Word

MS Project

Excel

Job description

Tarsus is seeking a Manager I, Regulatory Affairs Operations in Irvine, CA. You will manage electronic submission tools (Veeva Vault RIM) and drive the dossier lifecycle while aligning with FDA/EMA guidelines.

The role emphasizes planning, archiving, and coordinating cross‑functional teams to meet tight deadlines. You will lead content planning, support submissions, and help evolve regulatory operations processes.