Senior Manager, Regulatory Asset Oversight

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.

As Senior Manager, Regulatory Asset Oversight, you will partner with the GRL (Global Regulatory Lead) 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.

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.
• 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.
• Promote and drive the use of integrated Regulatory technologies to provide real-time, accurate submission status information.

Requirements:

• Degree in a biological, healthcare, or scientific discipline or extensive experience within the drug development environment.
• 5 years of regulatory affairs experience or similar relevant project management experience.
• 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.
• Good knowledge of Regulatory Affairs responsibilities from pre-IND through Post-Approval.
• Experience with diverse stakeholders and multifaceted assets.
• Experience with project management and resource management systems, tools, & reporting features.
• Ability to effectively lead multidisciplinary team meetings.

We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.