Senior Associate - Regulatory Project and Resource Management
This job is in your area. Enjoy a short commute and work close to home.
Job Description
7 - 10 Years of relevant experience in regulatory.
Independently use judgement, strict adherence to GSK and IRM plan quality and process expectations, industry and regulatory standards and drug development experience to deliver high quality integrated Regulatory Development Plans (RDPs) based on input from GRLs and project teams on the overall development strategies associated with projects (asset by indication)
Responsible for maintaining integrated Regulatory Development Plan (RDP) for operationalizing the Global Regulatory Strategy (as defined by the GRL), ensuring regulatory deliverables, timelines, and resource needs are accurately captured for each phase of development
Provide Regulatory functional line planning support at the project level (will support multiple projects under one Asset, if applicable) from Commit to Candidate (C2C) post-approval R&D activities
Manage work packages (add/delete/move as appropriate) within the RDP to ensure the necessary R...