GSK - Block 2D, Altron Campus, 20 Woodlands Dr, Woodmead, Johannesburg, 2191, South Africa
As a Regulatory Submissions Manager, you will work with global submission teams and third parties to project manage regulatory major submissions NDA/MAAs/BLAs, product line extensions, etc. in priority markets: US, EU, Japan and China from submission through to approval, ensuring that applications and dossiers are prepared to the highest quality standard and in a timely efficient manner. You will manage submission teams, lead discussion of deliverables and timings, facilitate scenario planning and perform impact analysis. You will utilize in-depth knowledge of global regulatory submission ...
