Manager, Regulatory Asset Oversight
il y a 2 jours
**Site Name**: Belgium-Wavre
**Posted Date**: Dec 13 2024
**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 Manager, Regulatory Asset Oversight role could be an ideal opportunity to explore.
As **Manager, Regulatory Asset Oversight**, you will create and manage integrated regulatory plans for purposes of operationalizing the Global Regulatory Strategy (GRS), and ensure team is on track to deliver per the Regulatory strategy. You’ll follow a consistent approach to Regulatory Asset oversight activities within and across project teams which best serve R&D Pipeline and key Established Products goals and ultimately the Patient.
This role requires the ability to professionally interact 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 Global Regulatory Leads (GRL) and Regulatory Matrix Teams (RMT) to 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.
- Employ 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 RMTs and Submission Delivery Excellence colleagues to identify and remove barriers that will prevent a successful outcome on defined filing strategies.
- Coordinate 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 escalates of issues and blockers to Sr. Manager, Regulatory Asset Oversight, and leadership as required.
- Utilize 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. Contributes to Regulatory Asset Oversight function metrics and KPIs.
- Leverage data from RIM systems to support RMT needs, ensuring its accurate, complete, 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
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.
- 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 organisation and with stakeholders outside of regulatory with ability to persuade and influence others (regardless of level) in achieving team objectives.
- Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable
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