Intern Regulatory Affairs Global Regulatory Affairs Development Strategy

INTERN REGULATORY AFFAIRS, GLOBAL REGULATORY AFFAIRS DEVELOPMENT STRATEGY Reports to: Manager Regulatory Affairs Location: Paris POSITION SUMMARY * Support the various regulatory activities of the portfolio team PRINCIPAL RESPONSIBILITIES * Preparation and submission of Clinical Trial Applications to National European Competent Authorities * Answer to questions from National Competent Authorities / Ethics Committees * Preparation of Pediatric Investigation Plan, Orphan Drug Designation or Scientific Advice applications * Regulatory intelligence for Orphan Medicinal Products QUALIFICATIONS * Have performed a first internship in the Industry * Have basic knowledge in clinical development * Dynamic and able to build working relationship, good team player and computer skills. * English both written and oral EDUCATION * PharmD: Pharmaceuticals studies * Master’s Degree: Regulatory Affairs COMPETENCIES * IT: microsoft pack office