Regulatory Resource Lead II

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. 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.

Find out more:

Our approach to R&D

Position Summary

You will lead regulatory activities that support submissions, approvals, and compliance across markets. You will work closely with cross-functional teams including regulatory affairs, clinical, quality, and commercial to plan and deliver regulatory strategies. We value people who are collaborative, detail-focused, and proactive. This role offers clear career growth, meaningful impact on public health, and alignment with GSK's mission of uniting science, technology and talent to get ahead of disease together.

Basic Qualifications:

• 6 - 10 Years of relevant experience in regulatory.
  
• Independently use judgement, strict adherence to GSK and IRM plan quality and process expectations, industry and regulatory standards and drug development experience to deliver high quality integrated Regulatory Development Plans (RDPs) based on input from GRLs and project teams on the overall development strategies associated with projects (asset by indication)
  
• Responsible for maintaining integrated Regulatory Development Plan (RDP) for operationalizing the Global Regulatory Strategy (as defined by the GRL), ensuring regulatory deliverables, timelines, and resource needs are accurately captured for each phase of development
  
• Provide Regulatory functional line planning support at the project level (will support multiple projects under one Asset, if applicable) from Commit to Candidate (C2C) è post-approval R&D activities
  
• Manage work packages (add/delete/move as appropriate) within the RDP to ensure the necessary Regulatory deliverables and agreed Global Reg Strategy are reflected; Must understand the importance of RDPs reflecting accurate development strategies through the management of these work packages and associate logic and touchpoints with other plan types
  
• Review and manipulate, as needed, the predecessor/successor logic within the RDP, create scenarios, and communicate what is driving Regulatory deliverable dates to the team and other PMs working on the project
  
• Perform scenario planning through developing alternative planning schedules, for development team and portfolio decision making
  
• Proactively partner with other functional plan owners/project managers from Medical, Safety, Clinical, etc., to ensure awareness of regulatory deliverables and alignment across all plan types within a project group
  
• Support R&D Governance reviews, e.g. Development Review Board (DRB) and Portfolio Investment Board (PIB), at key stage gates in the development process (e.g. C2P2, C2P3, C2F&L) as well as Dynamic Portfolio Review (dPR) – facilitate RMT and broader Regulatory review of resource forecasts (both external and internal project expenses – EPE, IPE, and FTE); Ensure any requested data is complete, accurate, and fit for purpose for informing business decisions
  
• With support from line managers/RPMs, as needed, build the associated schedules to drive Regulatory resource forecast estimates; forecast cost (EPE) and resource (FTE/IPE) associated with integrated plans
  
• Partner with key stakeholders including PMMT members and functional Project Managers, etc. to ensure plan schedule alignment to intended strategy.
  

Preferred Qualifications:

• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives
  
• Project management experience, preferably in the pharmaceutical industry or in a regulatory environment
  
• Ideally possessing knowledge of Regulatory Affairs responsibilities from pre-IND through post-approval
  
• Experience with project management principles and systems (e.g. Planisware), resource management and reporting features (e.g. Spotfire)
  
• Ability to work well both independently and within a matrix environment to ensure on-time delivery of objectives
  
• Strong project management skills and ability to work with stakeholders spanning multiple functional areas
  
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
  
• Must be able to work with minimal supervision in a complex organization contributing to the successful delivery of departmental objectives
  
• Must have project management and prioritization skills to enable successful delivery of projects and initiatives
  
• Ideally familiar with the overall concept of resource management and algorithmically driven resource forecast
  
• Ability to contribute to the assessment and interpretation of Regulatory resource needs in collaboration with functional line project managers and SMEs
  

GSK is committed to inclusion. We aim to create a workplace where everyone feels welcome and can do their best work.

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.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment- to discuss your needs.

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