Global Regulatory Affairs, Intercontinental Apprentice M/F

Les Ulis (France)
Student / Recent Graduate

The Job

Title: Global Regulatory Affairs, Intercontinental Apprentice M/F Company: Ipsen Innovation (SAS) Job Description: #IpsenTraineeSquad Ipsen is pleased to open a 12-monthapprenticeship (alternance) in the Global Regulatory Affairs, Intercontinental team! We are looking for a motivated Regulatory Affairsstudent to work in our R&D office in Les Ulis , France . Main responsibilities / job expectations To support global regulatory plans for the registration of new indications of an oncologic product in the Intercontinental region (APAC / LATAM / MEAM / NCE). Take part in strategic and/or operational tasks/discussions for lifecycle management activities. 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 Regulatory coordination Contributes to the drafting and implementation of the regulatory strategy (e.g. Regulatory Strategy Documents) for specific projects, ensures that the needs for his/her region are adequately reflected. Contributes to the preparation of the regulatory dossier with relevant functions and the assembly of regulatory documentation to be submitted according to the strategy validated. Contributes to critical and constructive review of regulatory dossiers (e.g. Marketing Authorisation Applications/New Drug Applications, New indication, Renewals, variations etc.) Ensures quality authoring of core-administrative parts of submission packages in the Intercontinental regions is collaboration with Regional Leads. Works on the content of regulatory submission dossiers in collaboration with GRA Manager Intercontinental and Regional Leads, to support ex-EU submissions. Ensures adequate planning and timelines management/adjustment depending on the deliverable. Attends/Drives meetings with cross-functional teams depending on deliverables Participates to the preparation of regulatory agencies consultations, if/when needed. Participates to the coordination of the responses to questions from authorities. Participates to the labelling activities Ensures adequate coordination of regulatory activities through reliable liaison with LRAs. Maintains a continuous flow of information with LRAs depending on the progress of projects, in collaboration with the Regional Leads. Ensures that the manufacturer is informed of the registered dossier to allow manufacturing in compliance with the terms of the marketing authorization. Strong collaboration with GRA Therapeutic Area and Labelling teams Compliance Operates according to Regulatory and Ipsen SOPs Ensures that registration status and lifecycle management updates are adequately reported in VREG (regulatory tracking tool) through data entry. Regulatory Intelligence Contributes to Regulatory intelligence, by tracking and analyzing the evolution of regulations relating to his/her areas. Assesses potential impacts for ongoing and future projects in collaboration with the team, creates reports/memos when applicable. 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.

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