Remote Regulatory Submissions Lead (EST Hours)

Syneos Health, Inc.; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

Syneos Health Regulatory Submission Manager role is remote with EST hours, overseeing submission plans for products in development and on-market in US/EU/global markets. The role supports regulatory teams and uses Veeva Vault RIM, eCTD, and project management tools to ensure timely submissions.

The position requires experience in publishing/submissions, strong organization, and the ability to work under firm deadlines.

Qualifications

• BS or MS with regulatory submissions experience
• Experience with FDA/EMA/ICH guidelines
• Knowledge of eCTD and regulatory information management systems

Responsibilities

• Oversee submission plans for products in development and on-market
• Coordinate with Vertex Publishing for regulatory submissions
• Translate timelines into project schedules and manage timelines

Skills

Regulatory submissions

Project management

Communication

Deadline-driven

Documentation

Education

B.S. in science

M.S. in science

Tools

Veeva Vault RIM

eCTD

Lorenz Publisher

Content Planning

Smartsheet

Microsoft Project

Excel

DXC ISI Toolbox

eCTD Viewers

Job description

Syneos Health Regulatory Submission Manager role is remote with EST hours, overseeing submission plans for products in development and on-market in US/EU/global markets. The role supports regulatory teams and uses Veeva Vault RIM, eCTD, and project management tools to ensure timely submissions.

The position requires experience in publishing/submissions, strong organization, and the ability to work under firm deadlines.