Regulatory Submissions Operations Lead

Tarsus Pharmaceuticals; Irvine (CA); Hybrid; USD 98,000 - 137,000; Full time

Benefits offered by this job

Stock equity

Comprehensive benefits

Hybrid work environment

Onsite gym and amenities

Job summary

Tarsus Pharmaceuticals, Irvine, CA, is seeking a Manager I, Regulatory Affairs Operations to help manage Veeva Vault RIM and regulatory submissions. You will lead content planning, timing, and collaboration with publishing vendors.

The role requires 5+ years in RA Operations, knowledge of FDA/EMA/ICH guidelines, experience with eCTD and Veeva systems, strong project management and attention to detail. Hybrid work with up to 20% travel is offered along with a comprehensive benefits package.

Qualifications

• Bachelor’s degree in science or health-related discipline or equivalent experience.
• Minimum of 5+ years of Regulatory Affairs Operations Experience, with a focus on publishing and/or submissions management, records management.
• Deep understanding of FDA, EMA and ICH guidelines.
• Experience with Veeva Vault RIM and regulatory document management.
• Ability to interpret regulations and policy statements with practical impact.
• Commitment to learning and process improvement.

Responsibilities

• Create and Maintain Content Plans within Veeva Vault RIM, understanding eCTD hierarchy.
• Assist with planning, archiving of submissions and dossier lifecycle management.
• Support RA submissions team with project management and tracking.
• Coordinate regulatory submissions with external publishing vendors.
• Work under deadlines and adapt to changing priorities.
• Help develop and optimize RA operations processes and systems.
• Maintain training records and complete required training.
• Utilize eCTD templates and submission tools.

Skills

Regulatory operations

Project management

Regulatory intelligence

Attention to detail

Collaboration

Education

Bachelor’s degree in science or health-related discipline

Tools

Veeva Vault RIM

Veeva RIMS

eCTD templates

DXC Toolbox

Job description

Tarsus Pharmaceuticals, Irvine, CA, is seeking a Manager I, Regulatory Affairs Operations to help manage Veeva Vault RIM and regulatory submissions. You will lead content planning, timing, and collaboration with publishing vendors.

The role requires 5+ years in RA Operations, knowledge of FDA/EMA/ICH guidelines, experience with eCTD and Veeva systems, strong project management and attention to detail. Hybrid work with up to 20% travel is offered along with a comprehensive benefits package.