Global Submissions & Operations Coordinator

Compass Consulting; Princeton (NJ); On-site; USD 85,000 - 125,000; Full time

Job summary

Compass Consulting seeks a Global Coordinator to support expanding international footprint by coordinating operational activities required to register, launch, and sustain products in global markets outside the United States. The role collaborates with Manufacturing, Supply Chain, Quality, Regulatory, and other internal stakeholders to ensure smooth submissions and market maintenance.

The successful candidate will be highly organized, process-driven, and able to manage multiple markets,

Qualifications

• Bachelor's degree in Manufacturing, Supply Chain, Life Sciences, Business, Operations, Engineering, or related discipline.
• 2-4 years of experience in pharmaceutical, biotechnology, medical device, or regulated industries.
• Experience coordinating cross-functional projects and stakeholders.
• Experience working with GxP documentation, electronic quality system (QMS), compliance, regulatory submissions, or operational processes.
• Global or international business experience preferred.

Responsibilities

• Global Expansion Coordination
• Coordinate cross-functional activities supporting global submissions, launches, and post-launch market maintenance
• Collaborate for operational activities across Manufacturing, Supply Chain, Quality, Regulatory, and other internal partners as needed
• Track critical milestones, deliverables, risks, decisions, and dependencies across multiple markets
• Facilitate communication and alignment between internal stakeholders and external commercial partners
• Document & Compliance Support
• Coordinate collection, maintenance, and distribution of operational and compliance documentation
• Manage recurring requests for market-specific documentation including CPPs, Certificates of Origin, GMP certificates, manufacturing declarations, quality documentation, and other submission support materials
• Identify document owners, approvers, and signature requirements
• Maintain organized repositories and standardized documentation packages to support reuse across markets
• Support development and continuous improvement of submission support tools, templates, and document libraries
• Apply working knowledge of GMP, GxP, and quality system requirements when coordinating documentation, compliance activities, and market-specific operational requests
• Operational Readiness & Market Maintenance
• Coordinate annual compliance activities and recurring market requirements
• Monitor, track and coordinate implementation of post-approval changes via their quality management system (QMS) and assess impacts across multiple markets and partners
• Support artwork, packaging, labeling, and product configuration coordination
• Assist with knowledge transfer activities and readiness planning associated with new market entries
• Ensure ongoing visibility of operational requirements as products progress from submission through commercial supply
• Process Management & Continuous Improvement
• Develop and maintain scalable processes that support increasing numbers of international markets
• Manage trackers, dashboards, and reporting tools for ROW activities
• Support development of their future global operating model and ROW support framework
• Maintain global market requirement databases and trackers
• Identify opportunities to automate, simplify, and standardize ROW processes
• Develop and implement systems and tools that improve coordination and visibility
• Develop reporting and metrics to support leadership decision-making

Skills

Exceptional organization and project协调

Attention to detail

Multitasking

Communication & stakeholder mgmt

Cross time zones & cultures

MS Office, SharePoint, Smartsheet

e-QMS experience

Process improvement

Education

Bachelor's degree in Manufacturing, Supply Chain, Life Sciences, Business, Operations, Engineering, or related discipline

2-4 years in pharma/biotech/medical device or regulated industries

Tools

Microsoft Office Suite

SharePoint

Smartsheet

e-QMS software

Job description

Compass Consulting seeks a Global Coordinator to support expanding international footprint by coordinating operational activities required to register, launch, and sustain products in global markets outside the United States. The role collaborates with Manufacturing, Supply Chain, Quality, Regulatory, and other internal stakeholders to ensure smooth submissions and market maintenance.

The successful candidate will be highly organized, process-driven, and able to manage multiple markets,