Senior Biosciences Program Manager (Regulatory & Submissions)

Soho Square Solutions; Milpitas (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Soho Square Solutions in Milpitas, CA seeks an experienced Senior Project/Program Manager to support a major global regulatory registration and product transition program within the Biosciences organization.

The role requires structuring complex work, building integrated plans, tracking progress, managing dependencies and risks, and communicating with senior stakeholders to drive timely decisions and accountability across the team.

Qualifications

• Bachelor’s degree in business, science, engineering, operations, information systems, or a related discipline.
• Ten or more years of progressive project or program management experience.
• Experience managing complex cross-functional projects in a regulated life sciences environment.
• Experience managing integrated plans, milestones, risks, issues, decisions, and accountability.
• Knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submission processes.
• Strong data management and reporting capabilities; SQL/BI skills a plus.
• Advanced Excel and Power BI proficiency; PowerPoint/Teams/SharePoint fluency.

Responsibilities

• Lead assigned projects and workstreams, translating objectives into scope, milestones and owners.
• Build integrated plans aligning regulatory, labeling, quality, R&D, ops, supply chain, commercial, and IT activities.
• Coordinate across functional leaders, monitor commitments, and drive timely deliverables in a matrix environment.
• Identify and manage risks, issues, actions, decisions, and resource constraints.
• Assess downstream impact of changes and escalate material items through governance channels.
• Facilitate planning sessions, risk reviews, and decision discussions.
• Ensure outcomes and approved changes are reflected in plans and reporting.
• Prepare concise status updates for teams and leadership, highlighting milestones and risks.
• Design and maintain project databases, trackers, dashboards, and reporting processes.
• Consolidate data from multiple streams to identify trends and leadership focus areas.
• Improve program reporting efficiency, including automation of recurring data collection.

Skills

Project management

Stakeholder management

Risk management

Analytical thinking

Communication

Excel

Power BI

Planning

Education

Bachelor's degree in business/science/engineering/related field

Tools

Excel

Power BI

SharePoint

Job description

Soho Square Solutions in Milpitas, CA seeks an experienced Senior Project/Program Manager to support a major global regulatory registration and product transition program within the Biosciences organization.

The role requires structuring complex work, building integrated plans, tracking progress, managing dependencies and risks, and communicating with senior stakeholders to drive timely decisions and accountability across the team.