Global Submissions & Compliance Coordinator (Hybrid)

Russell Tobin; Princeton (NJ); Hybrid; USD 52,000 - 61,000; Full time

Job summary

Russell Tobin is partnering with a leading biotechnology organization to identify a Global Coordinator to support international product registrations, launches, and ongoing market operations. This role will coordinate cross-functional activities, manage regulatory and compliance documentation, and drive process improvements across global markets within a regulated environment.

The position involves hybrid work with 60% onsite presence in Princeton, NJ, on a 1-year contract with potential

Qualifications

• Bachelor's degree required in a related discipline.
• 2–4 years of experience in a regulated industry.
• Experience coordinating cross-functional projects and stakeholders.
• Familiarity with electronic Quality Management Systems (e-QMS) and regulated workflows.
• Ability to manage multiple priorities and time zones.

Responsibilities

• Coordinate cross-functional activities supporting global submissions, product launches, and post-launch market maintenance across international markets outside the United States.
• Collaborate with Manufacturing, Supply Chain, Quality, Regulatory, and other internal stakeholders to ensure operational activities are completed efficiently.
• Track milestones, deliverables, risks, decisions, and dependencies across multiple markets and external partners.
• Coordinate the collection, review, maintenance, and distribution of regulatory, operational, and compliance documentation, including CPPs, Certificates of Origin, GMP certificates, and manufacturing declarations.
• Identify document owners, approvers, and signature requirements while maintaining organized repositories and standardized documentation packages.
• Support the development and continuous improvement of submission tools, templates, document libraries, trackers, and reporting dashboards.
• Coordinate annual compliance activities and recurring market-specific requirements.
• Track post-approval changes through the Quality Management System (QMS) and assess their impact across markets and commercial partners.
• Support artwork, packaging, labeling, product configuration, and readiness planning for new market entries.
• Develop and maintain scalable processes, global market requirement databases, and reporting tools to support international expansion.
• Identify opportunities to automate, simplify, and standardize operational processes while improving visibility, coordination, and reporting.
• Apply working knowledge of GMP, GxP, quality systems, and regulatory compliance requirements when coordinating documentation and operational requests.

Skills

GMP/GxP knowledge

Regulatory submissions

Cross-functional coordination

Quality systems

Documentation management

Education

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

Tools

Microsoft Office

SharePoint

Smartsheet

Job description

Russell Tobin is partnering with a leading biotechnology organization to identify a Global Coordinator to support international product registrations, launches, and ongoing market operations. This role will coordinate cross-functional activities, manage regulatory and compliance documentation, and drive process improvements across global markets within a regulated environment.

The position involves hybrid work with 60% onsite presence in Princeton, NJ, on a 1-year contract with potential