**Job title will be given depending on the experience**
Brief Position Description:
Senior Regulatory Operations Manager Role – this role provides supervision, leadership, and line management of the Regulatory Start up team. This role will ensure that line reports are trained and managed to regulatory authority (RA) and ethics committee (EC) submissions and approval according to ICH-GCP guidelines, local regulatory requirements, Novotech / client standard operating procedures (SOPs), and the Project Agreement.
Associate Director Regulatory Operations is the leadership position within the Clinical Services Division at Novotech. This position leads country Regulatory Start-up teams. It involves having functional responsibility over the start-up, dealing with external issues relating to meeting client deliverables, project revenues, resource management, staff development and training.
Responsibilities for Senior ROM:
Responsibilities for Associate Director, Regulatory Operations: