Job Description

Basic Qualifications:
7 - 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) e 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
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-adjustments@gsk.com to discuss your needs.
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Skills Required