Regulatory Portfolio Manager

Job content

Site Name: Upper Providence, GSK House, Wavre

Posted Date: Aug 11 2022

Are you interested in a project management role that allows you to accelerate regulatory compliance across the business? If so, this Regulatory Portfolio Manager could be an ideal opportunity to explore.

The Regulatory Portfolio Manager (RPM) will work with Regulatory Matrix Teams and Early/Medicine Development Teams to provide over-arching project management support to active Rx and Vx projects, spanning Commit to Candidate (C2C) through post-approval R&D activities. They will create and manage integrated Regulatory Development Plans, for purposes of operationalizing the Global Regulatory Strategy (GRS), forecasting resource requirements at the project level, and forecasting resource capacity at the functional level. They will drive execution of the Reg Dev Plan (RDP) and ensure team is on track to deliver per the Regulatory strategy, and engage with PMs across the business to ensure cross-functional alignment of key activites and milestones. They will also support monthly and quarterly governance reviews with respect to strategic resource management and optimization. The RPM will partner with Project Teams to assess acceleration mechanisms and embed them into the development plan, ensuring GSK’s upper quartile aspirational goals are achieved.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Provide overarching PM support at the project level (will support multiple projects under one Asset, if applicable) from Commit to Candidate (C2C)  post-approval R&D activities
• In close collaboration with the GRL and Reg Matrix Team, develops an integrated Reg Dev Plan for operationalizing the Global Regulatory Strategy and ensuring appropriate resource to deliver to the plan: 1-stop-shop that maps out deliverables, timelines, and resource needs for the entire project
• Provide visibility to Early Development Team (EDT) and Medicine Development Teams (MDT) of development plan and key deliverables within a project and across a portfolio (e.g. portfolio overview, executive summary, etc.)
• Perform scenario planning, impact analyses, critical path analyses
• Drive execution of the Regulatory Development Plan to ensure team is on-track to deliver per the Global Regulatory Strategy (GRS) and facilitate risk mitigation in response to any issues/risks that arise
• Proactively partner with functional contributors and SMEs to ensure awareness of upcoming deliverables, allowing for timely and effective engagement
• To ensure GSK’s competitiveness in drug development, work with teams to identify ways to optimize and accelerate project timelines, bringing products in our late-stage pipeline to market
• Lead project-level resource management activities, including facilitation of cost (EPE) and resource (FTE) forecasts and coordinating input for the Strategic Resource Management (SRM) process
• Support monthly and quarterly governance reviews (e.g. Portfolio Investment Board (PIB) and dynamic Portfolio Review (dPR) – facilitate RMT and broader Regulatory review of cost and resource demand outputs; Ensure any requested data is accurate, complete, and fit for purpose
• Strengthen project acceleration planning capability by working with PMs across functional line plans (MDP, PSAP, CSAP, VEO & Reg) to build fully integrated timelines with a clear view of the critical path and to challenge teams on how the critical path may be cross-functionally optimized
  

Why You?

Basic Qualifications

• Bachelor’s Degree in a biological, healthcare or scientific discipline
• Six or more years project management experience in the pharmaceutical industry or in a regulatory environment, overseeing and prioritizing multiple activities across one or more sites for multiple customers
  

Preferred Qualifications

• Bachelor Degree with training in Project Management skills/tools
• Detailed understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Knowledge of Regulatory Affairs responsibilities from pre-IND through Post-Approval
• Experience with project management and resource management systems, tools, reporting features (e.g. Spotfire) and how the various functional plans within an integrated PM system interact
• Ability to work well independently within a matrix environment to ensure on-time delivery of objectives/projects across cross-functional teams
• Ability to effectively lead multidisciplinary team meetings and drive discussions regarding Regulatory requirements, timelines, resource allocation, risk management, etc.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
• Demonstrated leadership and negotiation skills with ability to persuade and influence others (regardless of level) in achieving team objectives.
• Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
• Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of project progress/status.
  

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness.

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