PFor one of our clients, a global health care company, we are looking for an experienced Regulatory Submission Specialist.br / br / strongJob Description /strongbr / br / The Submission Specialist supports regulatory activities at study start up, focusing on submission to Ethics Committees (EC) and Competent Authorities (CA).br / br / strongResponsibilities /strong /pulliPrepare documents for Ethics Committee/Competent Authority (EC/CA) submission. /liliInitiate translation of documents as applicable; review and adapt translations as appropriate. /liliPrepare Country/Site Specific Patient Informed Consent form according to Regulatory and EC requirements and obtain internal approval where applicable. /liliInterpret clinical study protocols in order to support EC/CA submission /liliAct as the point of contact for EC /CA /liliSupport approval process /liliSupport budget adoption to country and site requirements. /liliPrepare submission to any other authority when applicable. /liliMaintain local regulatory documents on paper or electronically as applicable and ensure upload to appropriate system. /liliAssist with collection of site essential documents. /liliAttend project related meetings. /liliComply with all regulations in force, Company policies, operating procedures, processes, and task assignments. /liliInform manager if timelines appear to be at risk so that appropriate actions may be taken. /liliServes as a liaison to clinical teams and site personnel for administrative questions /li /ulpstrongRequirements /strong /pulliBachelor's or Master's degree, previous experience with EC/CA submissions /liliFluent in English, any other language is an asset /liliAbility to use discretion and handle sensitive/confidential information. /liliAbility to work independently when necessary. /liliAbility to exchange straightforward information, ask questions, and check for understanding. /liliAbility to multitask, prioritize and meet deadlines. /li /ulpstrongContract Information /strong /pulliFull-time position /liliOffice-based position in a dynamic, international environment /liliPermanent contract /li /ulpJOb number : 26637 /p