Julien Serusclat

Experience

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  Krêmlin-Bicêtre Hospital (Paris)

  Sept 2008 - Mar 2009

  Hospital pharmacy externship

  Implementation of a new traceability procedure for implantable medical devices in the endoscopy department

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  GSK

  May 2009 - Sept 2009

  Regulatory Affairs Intern

  • Submission of type II variations of the national Marketing Authorization: preparation of the local dossier and submission (electronic and paper) • Preparation of local Clinical trial applications and substantial amendment applications • Preparation and submission of the Five-year renewal application• Regulatory Validation of the medicine packaging items

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  Novartis

  Mar 2010 - Dec 2010

  European Regulatory Affairs Intern

  Cardiovascular and Metabolism Business Franchise• Key contribution to the pediatric program that secured the obtention of the extension of market exclusivity in Europe for a best-selling antihypertensive drug• Completed several Clinical Trial Applications and Amendments. Activities included planning, coordination with team members, creation and review of regulatory documents, liaison with affiliates and preparation of answers to health authorities • Planning and Preparation of several variation dossiers submitted via the Centralized Procedure and the Mutual Recognition Procedure Show less

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  Amgen

  Dec 2011 - Dec 2014

  Senior Regulatory Affairs Associate

  Oncology and Bone Diseases• International regulatory lead for multiple oncology and non-oncology clinical trials. Independently managed initiations, maintenance and closures of clinical studies in numerous countries worldwide. • Supported the EU filing lead in the preparation and execution of a key EU Regulatory Filing for an oncology product. Took charge of the creation of module 1 and part of Module 2 of the CTD Dossier. Successfully prepared briefing documents for pre-submission meetings. • Initiated, lead and managed an online training on clinical trial processes for Amgen staff in subsidiaries worldwide. Show less

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  ReNeuron

  Apr 2016 - Apr 2019

  Regulatory Affairs Project Manager

  • Preparation and submission of an initial IND for a controlled study of a genetically modified stem cell therapy in the USA• Management of various regulatory activities: EMA and FDA Scientific Advices, FDA Special Protocol Assessment, EU and US Orphan Drug Designations, Response to competent authorities' questions, IB updates, DSURs• Creation and amendments of quality sections of INDs and IMPDs and regulatory input into the development of comparability protocols to support significant changes of the manufacturing process• Representative of Regulatory Affairs in project teams for several products in clinical phase Show less