Senior Regulatory and Start Up Specialist

Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. Preparation of Clinical Trial Application Forms as well as preparation of submission dossier for submission to CA, EC and other applicable local bodies. Interaction with CA/EC for study purposes and handling responses to the CA/EC. Providing regular updates about CA and EC submissions to the Start Up Lead and to Project Manager/Project Team. Maintenance of project plans and regulatory intelligence tools. Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration. Prepare, review and manage collection of essential documents required for site activation/IMP release. Customize country/site specific Patient Information Sheet and Informed Consent Forms. Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines for the assigned sites in the country. Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials. May support the clinical team performing Pre-Study Site Visits. May interact with clients as required.