Regulatory Project and Data Manager

hace 4 semanas

Xoco, México GSK A tiempo completo

**Site Name**: Mexico City Torre Mitikah

**Posted Date**: Apr 9 2024
**_
Your Responsibilities_**: This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:

- 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.
- 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.

**_ Why you? _**

**_Basic Qualifications:_** We are looking for professionals with these characteristics 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.
- 5 years of experience understanding of 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, Microsoft Project), resource management and reporting features (e.g. Spotfire).
- Advanced English Level.
- Microsoft Office knowledge.

**_ Preferred Qualifications: _**However, if you have the following, it would be a plus:

- PMI or equivalent certification.
- Knowledge of Regulatory Affairs responsibilities from pre-IND through post-approval

**_ Why GSK? _**

Uniting science, technology and talent to get ahead of disease together 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.

**Why Us?**

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workp

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