Regulatory Project and Data Manager - Wavre, België - GSK

GSK

Geverifieerd bedrijf

Wavre, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Site Name:
UK - London - Brentford, Belgium-Wavre

Posted Date:
Feb

Regulatory Project and Data Manager - 1 Year FTC

You will work alongside a more senior Regulatory Portfolio Manager to create the RDPs, after which you 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.

You 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).

You will also support monthly and quarterly governance reviews with respect to strategic resource management and portfolio reviews.

In this role you will

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
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

_ Closing Date for Applications: 12th March 2023 (COB)_
Please take a copy of the Job Description, as this will not be available post closure of the advert.#LI-GSK

_ Why you?_

Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:

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
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
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 ontime delivery of objectives
Strong project management skills and ability to work with stakeholders spanning multiple functional areas
Must be able to work with mínimal 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
Ability to contribute to the assessment and interpretation of Regulatory resource needs in collaboration with functional line project managers and SMEs

Preferred

Qualifications & Skills:
If you have the following characteristics, it would be a plus: