Global Regulated Projects Manager, Life Sciences - Remote

Millenniumsoft; Milpitas (CA); On-site; USD 69,000 - 76,000; Full time

Job summary

Millenniumsoft is seeking a Project/Program Manager to support global regulatory registration and labeling transitions within the Biosciences organization. The role will own workstreams and coordinate activities across Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, Supply Chain, IT, and regional teams in Milpitas, CA.

The successful candidate will translate requirements into actionable plans, maintain project data, track milestones, and elevate material risks through

Qualifications

• Bachelor's degree in a related discipline is required.
• Six+ years of project or program management experience in regulated environments.
• Experience in medical devices, in vitro diagnostics, biotechnology, pharmaceuticals, or similar life-science fields.
• Experience creating and maintaining project plans, milestones, dependencies, risks, issues, actions, and decisions.
• Familiarity with dossiers/files, design controls, quality systems, labeling, regulatory submissions, or compliance remediation.

Responsibilities

• Lead assigned workstreams or execution packages with clear deliverables and owners.
• Develop and maintain detailed project plans aligned with regulatory timelines.
• Coordinate deliverables across functions and regions; ensure timely follow-up in a matrix setup.
• Maintain risks, actions, issues, decisions, and dependencies; escalate where needed.
• Facilitate planning sessions, readiness reviews, and risk discussions; document outcomes.
• Coordinate reviews and readiness activities for technical dossiers and documentation.
• Maintain accurate product and registration data; reconcile inconsistencies.
• Prepare status updates and dashboards highlighting milestones and risks.
• Ensure changes are reflected in plans and stakeholder communications.
• Identify opportunities to improve project controls and data quality.

Skills

Cross-functional coordination

Data management

Analytical skills

Stakeholder management

Multitasking

Communication

Problem solving

Education

Bachelor's degree in business/science/engineering/regulatory affairs/ops

Tools

Smartsheet

Microsoft Project

Power BI

Excel

PowerPoint

Teams

SharePoint

Job description

Millenniumsoft is seeking a Project/Program Manager to support global regulatory registration and labeling transitions within the Biosciences organization. The role will own workstreams and coordinate activities across Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, Supply Chain, IT, and regional teams in Milpitas, CA.

The successful candidate will translate requirements into actionable plans, maintain project data, track milestones, and elevate material risks through