GSK – Job vacancy for Regulatory Associate Manager II-Project and Data Management – Apply Now
About the job
Site Name: Bengaluru Luxor North Tower
Posted Date: Apr 3 2023
Ready to help shape the future of healthcare?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Job Purpose :-
The Regulatory Project and Data Manager (RPDM) will work with Regulatory Matrix Teams and Early/Medicine Development Teams to provide Regulatory functional line planning support and resource management to active Rx and Vx projects, spanning Commit to Candidate (C2C) through post-approval R&D activities.
The RPDM will own and provide active management of integrated Regulatory Development Plans (RDPs).
These plans will reflect the Global Regulatory Strategy for individual Vx and Rx projects.
The RPDM will work alongside a more senior Regulatory Portfolio Manager to create the RDPs, afterwhich they will work independently to maintain the plans, ensuring they continue to reflect the Global Regulatory Strategy as it evolves over time.
This includes adding appropriate Regulatory deliverables, updating timelines, manipulating the interdependencies and logic in the plan to ensure accurate timelines that drive key Regulatory milestones.
They will also engage with PMs across the business to ensure cross-functional alignment of the various plans within the project group, and communicate changes to the Reg strategy and timelines that impact other functional plans and the overall Medicine Development Plan (MDP).
The RPDM will also support monthly and quarterly governance reviews with respect to strategic resource management and portfolio reviews.
Key Responsibilities :-
- 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
Knowledge / Education / Previous Experience Required: –
- Educational Background :-
- Minimum Level of Education – Bachelor’s Degree in a biological, healthcare or scientific discipline or extensive experience within the drug development environment and training in project management principles/tools
- Preferred Level of Education – Bachelor’s degree with PMI or equivalent certification.
- Area of Specialisation – Science / Technical / Project Management
- Job-Related Experience :-
Minimum Level Of Job-Related Experience Required
- 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
Job-Related Experience sections above that are required for the job. :-
- 5 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
