Regulatory Project and Data Manager

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

Posted Date: Feb 24 2023

Regulatory Project and Data Manager

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. You 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.

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
• 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
  
  

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.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

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 on-time delivery of objectives
• Strong project management skills and ability to work with stakeholders spanning multiple functional areas
• 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
• 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:

• PMI or equivalent certification (highly sought after)
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ideally possessing knowledge of Regulatory Affairs responsibilities from pre-IND through post-approval
• Ideally familiar with the overall concept of resource management and algorithmically driven resource forecast
• Demonstrated experience in a range of role essential skills (e.g., data analysis, problem resolution, enterprise-wide project management tools)
• 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
  
  

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.

Find out more:

Annual Report 2021

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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