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Site Name: UK - London - New Oxford Street
Posted Date: Dec 13 2024
The Regulatory Asset Oversight Manager will partner with the 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.
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.
The Regulatory Asset Oversight Manager will facilitate the running of the RMT and acting as conduit for the GRL to the wider regulatory organisation and through their extended network engage with key partners outside of regulatory.
Will 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:
* 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.
* Assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g. Hyper-Acceleration, Acceleration in regions.
* Ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle.
* 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.
* Promote and drive the use of 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.
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
* Degree in a biological, healthcare, or scientific discipline or experience within the drug development environment.
* 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.
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
* Professional experience in a Submission delivery or Project Management role.
* Ability to effectively lead multidisciplinary team meetings drive discussions regarding, timelines, resource allocation, risk management, etc.
* 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.
* 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.
Closing Date for Applications - 10 Jan 2025 (COB)
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
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. #J-18808-Ljbffr