At IQVIA Mexico, we are currently looking for a **_Regulatory & Start Up Specialist_** to join our team!**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**- +2 years clinical research experience submitting clinical procedures to MoH in Mexico.- Essential experience handling COFEPRIS portal and logistics of submitting procedures in COFEPRIS.- Advanced command of English language.- Desirable experience in imports/exports (after the proper authorization of the protocol in the country).- Desirable experience in contract negotiations with sites.- Health regulation management of the country (General Health Law, NOMs, Agreements, latest guidelines with COFEPRIS**Work conditions**- Home based role- Based on ANY CITY within Mexico.