Apprenti CMC Regulatory - H/F

Title:

Apprenti CMC Regulatory - H/F

Company:

Ipsen Innovation (SAS)

Job Description:

• 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:

• Participate to the CMC regulatory strategy liaising with cross functional teams
• Check current regulations to ensure strategy is developed in alignment
• Participate to build, review and maintain CMC regulatory documentation for ongoing clinical programs (IMPD/IND)
• Participate in the authoring and reviewing phase of briefing documents for consultation with Regulatory Agencies
• Contribute to the CMC regulatory assessment of changes providing strategic regulatory advice and support the preparation of the corresponding variations/ amendments as required.
• Support the definition of the roadmaps build to guide the preparation of global dossier taking into account geographical specificities identified for submission to ensure dossier is in line with local regulatory requirements
• Support preparation of the strategy for response to question and participate in response authoring, review, submission and follow up
• Attend relevant project and non -project related team meetings

• Compliance

• Operates according to Regulatory and Ipsen SOPs
• Review and update trackers

• Regulatory Intelligence

• Contributes to Regulatory intelligence, by tracking and analysing the evolution of regulations relating to CMC topics;
• - Informs the relevant departments and answers their questions as needed.

• GRA Trainee Academy active team member

- Attend/Present at GRA 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 GRA Trainee Academy (specific program designed to provide a framework for the GRA 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.

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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.