Senior Manager, Regulatory Asset Oversight

il y a 2 jours

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre
**Posted Date**: Dec 13 2024
**Senior Manager, Regulatory Asset Oversight**:
Job purpose:
Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK? If so, this Senior Manager, Regulatory Asset Oversight role could be an ideal opportunity to explore.

As **Senior**Manager, Regulatory Asset Oversight**, you will partner with the Global Regulatory Leads (GRL) and Regulatory Matrix Teams (RMT) and Early/Medicine Development Teams to provide over-arching project management support to active Rx and Vx projects across the lifecycle of the asset. You’ll be responsible for promoting an agile and forward-looking culture which utilizes innovative technologies and techniques to develop comprehensive workplans which align with acceleration, efficiency, and compliance objectives.

You may be responsible for managing other Regulatory Asset Oversight Managers.

This role requires leadership within and across enterprise matrix teams including GRA (both central and at the Local Operating Company level), GRO, and contributing departments (e.g. Clinical Operations, Data Management, Stats and Programming) as needed to facilitate submission delivery expectations.

In this role, you will...
- Work in close collaboration with the GRL and RMT, develop and maintain a holistic view of the global regulatory integrated plan at the asset level for operationalizing the Global Regulatory Strategy and supporting the GRL in ensuring appropriate resource is engaged to deliver to the plan
- Drive the execution of the agreed plans to ensure team is on-track to deliver per the Global Regulatory Strategy (GRS), performing scenario planning, impact analyses, critical path analyses and facilitate risk mitigation in response to any issues/risks that arise.
- Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g. Hyper-Acceleration, Acceleration in regions.
- Implement a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle.
- Proactively partner as a Single Point of Contact with RMT, Submission Coordination, and Publishing colleagues to identify and remove barriers that will prevent a successful outcome on defined filing strategies.
- Drive the RMT Meeting and other Cross-Functional, Regulatory-Owned Engagements for success ensuring logistics, agenda topics and meeting materials are available and organized for the use of the team.
- Proactively identify upcoming activities or milestones which might impact regulatory deliverables and escalate of issues and blockers to the Director, Regulatory Asset Oversight, and leadership.
- Promote and drive the use of integrated Regulatory technologies to provide real-time, accurate submission status information (visuals and reports) for RMTs to highlight compliance from central dispatches through to registrations across markets. Maintains meaningful metrics and KPIs to assess individual and team performance which are aligned across the Regulatory Asset Oversight function.
- Support the GRL in the preparation of governance reviews leveraging data from RIM systems and ensuring accuracy, completeness, and fit for purpose.
- Facilitate discussions with LOCs and RMTs as needed to ensure aligned submission delivery strategy and efficient lifecycle filing strategies from lead markets through to regional expansion
- Serve as SME inputting to WoWs in conjunction with Stakeholders with a focus on continuous improvement, identification and implementation of automation opportunities, and compliance with Regulatory authority requirements.
- Maintain a network amongst GRA and R&D colleagues for awareness of best practices and identification of future opportunities

Why you?
- Basic Skills & Qualifications:_
- Degree in a biological, healthcare, or scientific discipline or experience within the drug development environment
- Good understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Extensive experience in the pharmaceutical industry or in a regulatory environment, overseeing and prioritizing multiple activities across multiple assets.
- Good knowledge of Regulatory Affairs responsibilities from pre-IND through Post-Approval.
- Knowledge of project management and resource management systems, tools, & reporting features
- Ability to effectively lead multidisciplinary team meetings drive discussions regarding, timelines, resource allocation, risk management, etc.
- Preferred Skills & Qualifications:_
- Good written and verbal communication skills and ability to present information in a clear and concise manner.
- Ability to effectively interact through different levels in the regulatory organization and with stakeholders outside of regulatory with ability to persuade and influence others (regardless

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