Global Regulatory Projects Coordinator

Insight Global; San Diego (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

Insight Global, within the biosciences sector, seeks a Project/Program Manager to plan and execute global regulatory registration and labeling transition programs. You will own workstreams across regions and product groups, coordinating Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, Supply Chain, IT, and regional teams.

You will translate requirements into actionable plans, maintain data accuracy, track milestones, escalate risks, and drive governance.

Qualifications

• Bachelor's degree in a relevant field.
• 4+ years of project or program management in a regulated environment.
• Experience with medical devices, in vitro diagnostics, biotech, pharma, or similar life-sciences.
• Experience developing and maintaining project plans, milestones, risks, issues, actions, and decisions.
• Familiarity with dossiers, design controls, quality systems, labeling, regulatory submissions, product registrations, or compliance remediation.
• Ability to coordinate deliverables across functions and drive timely follow-up in a matrix organization.
• Strong analytical and data-management skills to consolidate and validate information.

Responsibilities

• Lead assigned workstreams or execution packages with clear objectives, milestones, owners, dependencies, and target dates.
• Build and maintain detailed project plans aligned with integrated timelines across regulatory, labeling, quality, product, operations, and IT.
• Coordinate deliverables across functional and regional stakeholders; monitor commitments and drive closure in a matrix environment.
• Maintain risks, actions, issues, decisions, assumptions, dependencies; escalate schedule/resource/compliance concerns.
• Facilitate planning sessions, readiness reviews, and risk discussions; document decisions and owners.
• Coordinate technical dossiers and readiness reviews with SMEs; support submission-related dependencies.
• Maintain accurate product/registration data; reconcile inputs and resolve data issues.
• Prepare concise status updates and dashboards highlighting progress, milestones, risks, and support needs.

Skills

Integrated project planning

Cross-functional collaboration

Regulated life-sciences execution

Data-management

Governance & reporting

Excel proficiency

PowerPoint, Teams, SharePoint

Education

Bachelor's degree

Tools

Smartsheet

Microsoft Project

Job description

Insight Global, within the biosciences sector, seeks a Project/Program Manager to plan and execute global regulatory registration and labeling transition programs. You will own workstreams across regions and product groups, coordinating Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, Supply Chain, IT, and regional teams.

You will translate requirements into actionable plans, maintain data accuracy, track milestones, escalate risks, and drive governance.