Alternance - Global Regulatory Affairs, EU Region and Communication M/F

Les Ulis (France)
Student / Recent Graduate
Business & Management

The Job

Title: Alternance - Global Regulatory Affairs, EU Region and Communication M/F Department: Regulatory Transformation & Strategic Projects (Stephane SIMON) Job Description: #IpsenTraineeSquad Ipsen is pleased to open a 12-monthapprenticeship (alternance) in the Global Regulatory Affairs, Oncology team! We are looking for a motivated Regulatory Affairsstudent to work in our R&D office in Les Ulis , France. Please provide a cover letter ( lettre de motivation ) in addition to your application. Region and Regulatory coordination The apprentice will support the coordination of the EU Regulatory Affairs activities with relevant functions and the assembly of regulatory news (EMA), strategic information and department's last news to be presented during EU follow-up forums. Ipsen's European Affiliates are fundamental links for Ipsen's business expansion. The apprentice will ensure adequate coordination of regulatory activities through reliable liaison with LRAs. He/she will also maintain a continuous flow of information with LRAs depending on the progress of projects. The apprentice will contribute to constructive leadership decisions with the VP and European Region Manager. He/she will also contribute to the development of an efficient tracker for the Region Coordination, and of promotional material (videos, infographics...). Regulatory Activities Works on the content of regulatory submission dossiers in collaboration with GRA Director on EU/Intercontinental marketing authorization renewals and variations: including packaging and labelling review, cover letters and present-proposed writing, dossier submission and follow-up. Depending on the needs, may be solicited to help on the definition of the regulatory strategy (e.g. Regulatory Strategy Documents) for specific projects. Transversal and communication activities Helps on the development of GRQ community. Update the org chart of our organisation. Major role on organizing our annual seminar. Develop corporate news to communicate about GRQ activities. Might be asked to collaborate with digital and biometry R&D teams if interested by digital health and innovative tools (AI, RWD...). Compliance Operates according to Regulatory and Ipsen SOPs Regulatory Intelligence Contributes to Regulatory intelligence through the consultation of Regulatory Database and enquiries toward Local Regulatory Affairs contact points. 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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