Regulatory Submission Coordinator

Syneos Health

Regulatory Submission Coordinator supporting Regulatory Leads for Rare Disease products. Collaborating on submissions and managing content plans using Veeva Vault RIM.

Posted 8/3/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory submission processes and project management within the Rare Disease sector, utilizing tools such as Veeva Vault RIM and Microsoft Project for effective planning and communication.

Highest-signal resume keywords

Regulatory Submission ManagementVeeva Vault RIMMicrosoft ProjectSmartsheetCross-Functional Collaboration

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Submission PlanningContent Plan CreationTimeline TranslationProject ManagementAttention to Detail

Soft Skills

Excellent OrganizationWritten CommunicationVerbal CommunicationAdaptabilityNegotiation

Tools & Technologies

Veeva Vault RIMMicrosoft ProjectSmartsheet

Industry Keywords

Rare DiseaseRegulatory AffairsSubmission CoordinationPublishing Communication

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

support Regulatory Leads for a portfolio of development and registered products in the Rare Disease space
Create and Maintain Content Plans within Veeva Vault RIM
Translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM
Assist with planning, managing, and tracking of regulatory submissions
Assist with coordination and communication of regulatory submissions to Publishing
Arranging and leading submission planning meetings
Negotiating deadlines and following up with cross-functional stakeholders
Must be able to work with firm deadlines and adapt quickly to changing requirements and priorities.

Requirements

What you’ll need

support Regulatory Leads for a portfolio of development and registered products in the Rare Disease space
Create and Maintain Content Plans within Veeva Vault RIM
Translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM
Assist with planning, managing, and tracking of regulatory submissions
Assist with coordination and communication of regulatory submissions to Publishing
Arranging and leading submission planning meetings
Negotiating deadlines and following up with cross-functional stakeholders
Excellent organization, written/verbal communication to explain difficult information, and attention to detail a must.

Benefits

Comp & perks

We are passionate about developing our people, through career development and progression
supportive and engaged line management
technical and therapeutic area training
peer recognition and total rewards program
We are committed to building an inclusive culture – where you can authentically be yourself.