Senior Manager - Regulatory Project and Resource Management (HIV)

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

This role sits within the Regulatory Excellence function of GSK’s Research & Development (R&D) division, which leads and orchestrates regulatory excellence across Global Regulatory Affairs (GRA) to ensure high-quality, compliant and timely submissions to Health Authorities. The role reports into a Director for Regulatory Operational Excellence, and is aligned to provide expertise to GSK’s HIV medicines portfolio. Job-purpose: The Regulatory Project and Resource Manager (RPRM) provides end-to-end regulatory planning and resource expertise and management for a portfolio of development projects, translating Global Regulatory Strategy into integrated, executable and governance-ready Regulatory Development Plans (RDPs). The role manages planning, resource and cost forecasts, scenario analysis and portfolio insights to support effective regulatory delivery and informed portfolio decision-making.

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 (Chemistry, Manufacturing and Controls), 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.

About You: This role is a great opportunity to be instrumental in developing and delivering GSK’s R&D aims. As this role is multi-faceted and includes collaborating / liaising with a wide variety of stakeholders and matrix teams you must have strong experience of working in complex matrix-environment, with demonstrable clear problem-solving approach to your work and a track‑record of delivery. Strong people skills and a proven ability to influence people to achieve and drive performance are also pre-requisites for this role.

Basic 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).

Skills

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

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most.

Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels.

Application closing date – Friday 30th of October 2026 (COB).

GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.