Global Submission Lead EU/LA/ROW since 2005.Professional Skills: •Knowledge and experience in the clinical study start up requirements and activities for all assigned countries (or the ability to find this out for new countries)•Bid Defense meetings•Pre-kick-off meetings•Kick off meetings•VHP Experience•Pediatric Experience•Creation of the study start up department in Spain (Spain and Portugal)•SIS/ICF EU Master population/review and country SIS/ICF adaptation•Preparation of EU Application Form (Core and country)•Request of EudraCT nº for Sponsor•Training of new study start up colleagues and Clinical employees (Spain and Portugal)•Preparation of EC and CA submission (including observational studies)- (Spain, France and Portugal)•Mentoring and supervising•Good organizational skills and the ability to manage multiple tasks but also task focused•An excellent level and proven experience high standards of attention to detail•Good written and verbal communication skills - Proficient in English and language required for country assignments•Ability to liaise with colleagues from Study Start Up, other departments and clients•Strong project management skills•Highly developed problem solving skills. Solution-focused•Strong people management and effective communication skills•Customer service focused•Competent computer skills•Languages: French (Fluent oral and written), Spanish (Fluent oral and written) English (Fluent oral and written) and Galician (Fluent oral)