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) post-approval RD 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 RD 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, C2FL) 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 RD 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
