global labelling apprentice

SUMMARY / PURPOSE OF THE POSITION The position offers a 12 MONTHS APPRENTICESHIP in Global Labelling and reports to the Head of Global Regulatory Labelling. * To support global labelling updates for all countries * To support remediation project and support countries outside of EU for comparing their local label to the Company Core Documents * To support countries for country product information implementation worldwide and manage management of labelling discrepancies Anticipated Start date: September 2022 MAIN RESPONSIBILITIES / JOB EXPECTATIONS * 12 months apprenticeship – weekly schedule can be flexible and discussed during interview * Resume and cover letter (Lettre de motivation) are expected to apply for the position * LABELLING COORDINATION * Contributes to the drafting of CCDS with relevant functions, work with GRA to ensure regulatory strategy (registration plan, timelines) is taken into account, and competitive environment assessed (comparison of competitive labels) * Support countries for the implementation of the requested CCDS changes into local PI, ensures the specificities of the country (rationale for different wording/submission timelines) are adequately reflected in non-conformance documents. * Coordinate relevant functions to ensure adequate data support CCDS update and define submission package needed and timelines * Ensures adequate planning and timelines management/adjustment depending on the deliverable. * Organize and support cross functional meetings with Project team for CCDS development * Participates to the responses of labelling questions from authorities. * COMPLIANCE * Operates according to Regulatory and Ipsen SOPs * REGULATORY INTELLIGENCE * Contributes to Regulatory intelligence, by tracking and analysing the evolution of regulations relating to his/her areas; * Informs the relevant departments and answers their questions. * GRQ AND GRQ TRAINEE ACADEMY ACTIVE TEAM MEMBER * Attend/Present at GRQ knowledge sharing meetings * Attend Ipsen internal events (Presentations, external speakers, forums, webinars, celebrations …) * Ensures adequate reporting of his/her activities and participates to various meetings depending on project assignments * Be an active member of the GRQ Trainee Academy (specific program designed to provide a framework for the GRQ interns and apprentices only): attending proposed trainings, prepare webcast, share experience, build network, site visits (if possible), get exposure to senior management. Provide feedback and participate in Trainee Academy further development and visibility. * EHS MISSIONS * Respect the regulations and EHS procedures in force. * Participate in the EHS performance of the site by reporting risks, malfunctions or improvements. * Participate in mandatory EHS training. Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.