Senior Manager, Regulatory Asset Oversight

GSK

17d•Hybrid

About The Position

The Senior Manager, Regulatory Asset Oversight 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. As Senior Manager, Regulatory Asset Oversight you will create and manage integrated regulatory plans, and ensure team is on track to deliver per the Regulatory strategy. Will be responsible for ensuring 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. Collaborates and networks across the R&D matrix to ensure that project management and submission oversight activities are agreed and aligned to efficiently support R&D portfolio aspirations. Coordinates with Submission Delivery Excellence colleagues on the operational execution of the strategy. 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. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practices, and this role operates under a hybrid working model only. Our Performance with Choice programme empowers you to find the optimal balance between remote and in-office work within this framework.

Requirements

Degree in a biological, healthcare, or scientific discipline or extensive experience within the drug development environment.
Good understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
Strong project management expertise 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.
Experience with 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.

Nice To Haves

Training in project management skills/ tools
Excellent 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 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.

Responsibilities

Develop and maintain a holistic view of the global regulatory integrated plan at the asset level in collaboration with the GRL and RMT.
Drive the execution of agreed plans, performing scenario planning, impact analyses, and risk mitigation.
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
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.

Benefits

competitive salary
annual bonus based on company performance
healthcare and wellbeing programmes
pension plan membership
shares and savings programme
Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours.
Established job in an international, well-known pharmaceutical company.
Opportunity to work in professional team plays crucial role in maintaining GSK portfolio on the markets.
Opportunity to work within GSK standards and documentation applied globally.
Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus).
Supportive & friendly working environment.