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 support activities that help bring our science and technology to patients. You will work with regulatory, cross-functional project teams and external partners to plan and deliver regulatory submissions and maintain compliance. We value people who are organized, collaborative, curious and driven to learn. This role offers visible growth, the chance to influence regulatory strategy, and meaningful impact aligned with our purpose of uniting science, technology and talent to get ahead of disease together.
The Resource Lead, Submission Delivery Excellence will responsible for driving continuous improvement initiatives in one or more of the following areas:
Project management/PMO • Data analytics/visualization Resource allocation (Strategic) Risk and Issue Management This role will ensure the optimization of strategy with the functional teams and translate the same in the PM tool.
Key Responsibilities:
• Input to and execute on the regulatory excellence strategy aligned with the goals of the Regulatory Excellence function with a focus on one of more of the following: Analyze and enhance current project management methodologies and practices to ensure the successful delivery of regulatory projects. Lead the development of an analytics framework and manage the output to support the development, interpretation and provision of key performance indicators and analyses, providing actionable insights that inform the GRA LT and functional lines to improve decision-making o Lead the development and implementation of resource allocation strategies to ensure optimal use of personnel and other resources, facilitating resource management reviews with the LT as needed • Drive a continuous improvement mindset across the team to ensure the most efficient and optimal processes, tools are being utilized
Foster a culture of continuous improvement by providing training, coaching, and mentorship to junior members of the team
Good to have PMP Certificate / Preferable PMP Certification (Pursuing or completed)
sound knowledge and experience in Project Management and Resource Management
Hands on experience in any Project Management Tool.
Experience working in Matrix environment.
Why You?
This role requires knowledge in drug development expectations and project management principles/tools and the ability to engagement with stakeholders with comparable expertise.
Basic Qualification
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) à 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 associated 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 RMT members and functional Project Managers, etc. to ensure plan schedule alignment to intended strategy
Preferred Qualification
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 organisation contributing to the successful delivery of departmental objectives
Must have project management and prioritisation 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
7 years of experience understanding of pharmaceutical business, drug development, and project management
Demonstrated experience in a range of role essential skills (e.g., data analysis, problem resolution, enterprise-wide project management tools)
Ability to present data and visualizations based on the needs of the target audience
Natural curiosity and the ability to explore new ideas and interrogate data
Strong sense of urgency and ability to effectively prioritize, such that key issues/matters are handled in a timely and effective way
Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment
Demonstrated ability to think flexibly in order to meet constantly shifting priorities and timelines
Excellent organizational skills, attention to detail and commitment to deliver high quality output
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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