Regulatory Planning Lead — HIV Portfolio

GSK

Greater London

Vor Ort

GBP 65.000 - 90.000

Vollzeit

Vor 6 Tagen
Sei unter den ersten Bewerbenden

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Zusammenfassung

GSK in the UK is seeking a Regulatory Project and Resource Manager to lead end‑to‑end regulatory planning across a portfolio of development projects. You will translate Global Regulatory Strategy into integrated Regulatory Development Plans (RDPs), manage timelines, dependencies and governance readiness in Planisware.

In this role you will own FTE and cost forecasting, manage External Project Expenditure forecasts, and provide portfolio insights to mitigate risks and enable timely regulatory

Qualifikationen

  • Demonstrated regulatory project and resource management experience within pharmaceutical R&D.
  • Advanced knowledge of Planisware (or equivalent portfolio planning tool).
  • Proven ability to independently manage a large, complex portfolio of regulatory development projects with governance requirements.
  • Strong working knowledge of integrated planning (FTE/cost forecasting, scenario planning).
  • Knowledge of HIV drug development or similar specialty portfolio experience.
  • Ability to work with senior cross-functional stakeholders across Regulatory, Clinical, Safety, CMC, PM, and Finance.
  • Strong analytical and stakeholder-management skills with the ability to provide portfolio-level insights.

Aufgaben

  • Owning and actively managing integrated Regulatory Development Plans (RDPs) to translate regulatory strategy into deliverables.
  • 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 forecasts and align plans with regulatory costs.
  • Supporting dynamic Portfolio Review and governance cycles with validated plans.
  • Scenario planning and impact assessments for changes to development or regulatory strategy.
  • Partnering with GRLs, RMTs, PPMs, Clinical, Safety, CMC, Finance and other stakeholders to ensure alignment and timely updates.

Kenntnisse

Agile Planning
Business Acumen
Change Management
Digital Fluency
Influencing Without Authority
Learning Agility
Problem Solving
Regulatory Strategies

Tools

Planisware

Jobbeschreibung

GSK in the UK is seeking a Regulatory Project and Resource Manager to lead end‑to‑end regulatory planning across a portfolio of development projects. You will translate Global Regulatory Strategy into integrated Regulatory Development Plans (RDPs), manage timelines, dependencies and governance readiness in Planisware.

In this role you will own FTE and cost forecasting, manage External Project Expenditure forecasts, and provide portfolio insights to mitigate risks and enable timely regulatory

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