Strategic Regulatory Planning Manager (HIV Portfolio)

GSK; Irvine; On-site; GBP 70,000 - 110,000; Full time

Job summary

GSK is seeking a Regulatory Project and Resource Manager to lead end-to-end regulatory planning for a HIV development portfolio. You will translate regulatory strategy into executable development plans, manage timelines, resources and costs, ensuring governance-ready deliverables across Global Regulatory Affairs.

The role emphasizes Planisware planning, scenario analysis, and proactive risk management in a complex matrix environment, partnering with GRLs, RMTs, PPMs, Clinical, Safety, CMC and

Qualifications

• Demonstrated experience in regulatory project and resource management within pharmaceutical R&D, including integrated Regulatory Development Plan (RDP) management.
• Advanced knowledge of Planisware (or equivalent enterprise portfolio planning tool).
• Proven ability to independently manage a large and complex portfolio of regulatory development projects with multiple concurrent priorities and governance requirements.
• Strong working knowledge of integrated planning (including FTE/resource forecasting, cost forecasting, and scenario planning).
• Knowledge of HIV drug development and HIV regulatory landscape (or substantial experience supporting a similar portfolio).
• Ability to work with senior cross-functional stakeholders across Regulatory, Clinical, Safety, CMC, Project Management, and Finance.
• Strong analytical and stakeholder management skills to provide portfolio-level insights for governance decisions.

Responsibilities

• Owning and actively managing integrated Regulatory Development Plans (RDPs) to translate regulatory strategy into deliverables (timelines and dependencies).
• Managing regulatory planning across a complex portfolio and identify planning and delivery risks.
• Owning FTE/resource forecasting to maintain accurate forecasts.
• Managing External Project Expenditure (EPE) forecasts and align plans, resources and regulatory costs.
• Supporting dynamic Portfolio Review (dPR) and governance cycles with governance-ready plans and forecasts.
• Perform scenario planning and impact assessments for changes to development or regulatory strategy.
• Partner with Global Regulatory Leads, Regulatory Matrix Teams, Process Performance Managements, Clinical, Safety, CMC, Finance and other stakeholders for alignment.
• Provide portfolio-level planning, forecasting and variance insights to support proactive decision-making.

Skills

Agile Planning

Business Acumen

Change Management

Digital Fluency

Influencing Without Authority

Learning Agility

Problem Solving

Regulatory Strategies

Tools

Planisware

Job description

GSK is seeking a Regulatory Project and Resource Manager to lead end-to-end regulatory planning for a HIV development portfolio. You will translate regulatory strategy into executable development plans, manage timelines, resources and costs, ensuring governance-ready deliverables across Global Regulatory Affairs.

The role emphasizes Planisware planning, scenario analysis, and proactive risk management in a complex matrix environment, partnering with GRLs, RMTs, PPMs, Clinical, Safety, CMC and