GSK - Block 2D, Altron Campus, 20 Woodlands Dr, Woodmead, Johannesburg, 2191, South Africa
Role Purpose：To provide strategic and technical CMC regulatory input for the purpose of commencing and maximizing GSK China business by facilitating the CMC submission and approval in a timely and high-quality manner.Key Accountabilities/Responsibilities：In charge of all CMC regulatory relevant activities of assigned new products IND/CTA/NDA and established products life cycle management, including CMC strategy making and implementation, CMC document preparation, CDE CMC technical review follow up, HA CMC meeting or communication for CMC topics, QC testing, GMP on-site inspection...
