Senior Regulatory Program Manager, Biosciences - Remote

Lancesoft; Milpitas (CA); On-site; USD 110,000 - 165,000; Full time

Job summary

Lancesoft in Milpitas, CA is seeking a Senior Project/Program Manager (Contractor) to drive a global regulatory registration and product transition program within Biosciences. This on-site role may offer remote work for stellar candidates based on experience.

You will build integrated plans across regulatory, labeling, quality, IT, and operations; manage risks and dependencies; and report progress to senior stakeholders. Strong analytical, data management, and communication skills are essential.

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 or workstreams in a regulated life sciences environment.
• Demonstrated experience managing integrated plans, milestones, dependencies, risks, issues, decisions, and accountability across multiple functions.
• Working knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submission processes.
• Strong analytical and data management capabilities, including experience developing project databases, dashboards, and data-driven reporting solutions.
• Advanced proficiency with Excel and strong proficiency with Power BI or a comparable data visualization tool.
• Proficiency with PowerPoint, Teams, SharePoint, and project planning or collaboration tools.
• Strong written, verbal, facilitation, presentation, and stakeholder management skills.
• Ability to influence and drive accountability without direct authority.

Responsibilities

• Lead assigned projects and workstreams, translating program objectives into clear scope, deliverables, milestones, owners, dependencies, and target dates.
• Build and maintain integrated project plans that align regulatory, technical documentation, labeling, quality, R&D, operations, supply chain, commercial, and IT activities.
• Coordinate across functional leaders and subject matter experts, monitor commitments, resolve planning gaps, and drive completion of deliverables in a matrix environment.
• Identify and manage risks, issues, actions, decisions, assumptions, schedule conflicts, and resource constraints.
• Assess the downstream impact of changes and delays, establish mitigation plans with accountable owners, and escalation material items through appropriate governance channels.
• Facilitate cross-functional planning sessions, working meetings, risk reviews, and decision discussions.
• Ensure meeting outcomes, approved decisions, and changes are reflected in project plans, reporting, and communications.
• Apply working knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submissions to support appropriate planning, sequencing, documentation readiness, and submission readiness.
• Prepare concise status updates for project teams and leadership, highlighting progress, upcoming milestones, overdue actions, risks, dependencies, decisions, and required support.
• Design and maintain practical project databases, trackers, dashboards, and reporting processes.
• Consolidate information from multiple workstreams and analyze project data to identify trends, emerging risks, and areas requiring leadership attention.
• Improve the quality, consistency, and efficiency of program reporting, including opportunities to simplify or automate recurring data collection.

Skills

Project management

Stakeholder management

Cross-functional teamwork

Data analysis

Reporting

Education

Bachelor’s degree in business/science/engineering/operations/information systems or related discipline

Tools

Excel

Power BI

PowerPoint

Teams

SharePoint

Job description

Lancesoft in Milpitas, CA is seeking a Senior Project/Program Manager (Contractor) to drive a global regulatory registration and product transition program within Biosciences. This on-site role may offer remote work for stellar candidates based on experience.

You will build integrated plans across regulatory, labeling, quality, IT, and operations; manage risks and dependencies; and report progress to senior stakeholders. Strong analytical, data management, and communication skills are essential.