Intern Global Regulatory Affairs Development Strategy

TITLE: INTERN GLOBAL REGULATORY AFFAIRS DEVELOPMENT STRATEGY (GRA-DS) REPORTS TO: ASSOCIATE DIRECTOR, GRA-DS, META+ THERAPEUTIC AREA LOCATION: LEVALLOIS-PERRET, FRANCE Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. As a leader in rare diseases for nearly 30 years, Alexion is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialisation of life-changing medicines. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on haematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. More information about Alexion can be found at: www.alexion.com. POSITION SUMMARY The intern will provide support in the execution of various regulatory activities in line with the agreed regulatory strategy for the Meta+ portfolio products, leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. The individual will also ensure effective communication and constructive working relationships with internal partners and representatives of regulatory authorities. PRINCIPAL RESPONSIBILITIES • Works Global Regulatory lead (GRL) and Regulatory Sub team to execute regulatory activities. * Prepares and submits Clinical Trial Applications to National European Competent Authorities. * Provides support in the preparation of Scientific Advice, pre-submission and marketing authorization applications * Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs * Provides support to regulatory affairs reviewers for due diligence initiatives. * Ensures exemplary behavior, ethics and transparency within the company and with regulatory agencies QUALIFICATIONS • Basic knowledge in clinical development * Dynamic and able to build working relationship, good team player and computer SKILLS • Strong interpersonal and written/verbal communication skills. * Ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines; EDUCATION • Student in Pharmacy or equivalent scientific degree (5+ years), with a preference with Master's Degree in Regulatory Affairs * First experience in the pharmaceutical or other related industry COMPETENCIES • English both written and oral * Microsoft Office Pack (profficient)