Regulatory & Start Up Specialist, Cfsp

We are looking for a **Regulatory & Start Up Specialist** to join our cFSP team in a Home Based role!**Location**: Argentina & México**What You´ll Do**Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.- Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.- Prepare site regulatory documents, reviewing for completeness and accuracy.- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.- Perform quality control of documents provided by sites.- May have direct contact with sponsors on specific initiatives.**What Will Help You Succeed**- Health Sciences degree or related field.- +3 years of clinical research experience within regulatory area: local regulatory submissions, knowledge of ICF, presentations to ethics committee, (COFEPRIS/ANMAT).- Advanced command of English language.- Good organizational and time management skills- Good communication and interpersonal skills