Regulatory Project & Resource Lead – HIV Portfolio

GSK; Camden Town; On-site; GBP 55,000 - 90,000; Full time

Job summary

GSK is seeking a Regulatory Project and Resource Manager within Regulatory Excellence in the HIV portfolio. You will translate regulatory strategy into the Regulatory Development Plans and manage cross-functional planning in Planisware.

Reporting to a Director for Regulatory Operational Excellence, you will own forecasting, scenario analysis, and governance-ready plans, collaborating with GRLs, RMTs, PPMs, Clinical, Safety, CMC and Finance.

Qualifications

• Demonstrated experience in regulatory project and resource management within pharmaceutical R&D, including integrated Regulatory Development Plan (RDP) management.
• Advanced knowledge of Planisware (demonstrated experience with Planisware or an 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 and understanding of HIV drug development and the HIV regulatory landscape (or substantial experience supporting a similarly complex specialty pharmaceutical portfolio).
• Demonstrated ability to work with senior cross-functional stakeholders across Regulatory, Clinical, Safety, CMC, Project Management, and Finance.
• Strong analytical and stakeholder management skills with the ability to identify planning and resource risks and provide reliable portfolio-level insights (to support governance decisions).

Responsibilities

• Owning and actively managing integrated Regulatory Development Plans (RDPs) - in Planisware - to translate regulatory strategy into deliverables (including timelines and dependencies).
• Managing regulatory planning across a complex portfolio of development projects and proactively identify planning and delivery risks.
• Owning FTE/resource forecasting across regulatory functions to maintain accurate and near-to-reality forecasts.
• Managing External Project Expenditure (EPE) forecasts and ensure alignment between project plans, resources and expected regulatory costs.
• Supporting dPR (dynamic Portfolio Review) and relevant governance cycles, ensuring plans and forecasts are accurate, validated and governance-ready.
• Perform scenario planning and impact assessments to evaluate timeline, resource and cost implications of changes to development or regulatory strategy.
• Partner with Global Regulatory Leads (GRLs), Regulatory Matrix Teams (RMTs), Process Performance Managements (PPMs), Clinical, Safety, CMC, Finance and other stakeholders to ensure alignment and timely incorporation of changes.
• 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 within Regulatory Excellence in the HIV portfolio. You will translate regulatory strategy into the Regulatory Development Plans and manage cross-functional planning in Planisware.

Reporting to a Director for Regulatory Operational Excellence, you will own forecasting, scenario analysis, and governance-ready plans, collaborating with GRLs, RMTs, PPMs, Clinical, Safety, CMC and Finance.