Job Title: Global Regulatory Affairs, Oncology Apprentice
Division / Function: Global Regulatory Affairs (GRA), Oncology
Manager (Name, Job Title): GRA Senior Director or GRA Director, Oncology
Location: Paris
Summary / purpose of the position:
The position offers a 12 months apprenticeship in Global Regulatory Affairs, Oncology
- T o support global regulatory development and registration plans supporting commercialization, both pertaining to Europe/US/Canada/China/Japan.
- Take part of strategic and operational tasks/discussions for early and/or late stage programs.
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
· 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.
- Supports the coordination of the preparation 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 (MAA/NDA, New indication, CTA, special designation, pediatric development, etc.)
- Ensures quality authoring of core-administrative parts of submission packages.
- Works on the content of regulatory submission dossiers in collaboration with GRA Director and approves change control.
- Ensures adequate planning and timelines management/adjustment depending on the deliverable.
- Attends/Drives cross functional meetings with Project team depending on deliverables
- Supports Europe marketing authorization procedures (centralized, decentralized, and/or MRPs) with support from GRA Director and Local Regulatory Affairs (LRAs) when applicable.
- Supports NDA/sNDA/Health Canada submissions when applicable.
- Participates to the preparation of regulatory agencies consultations (e.g. EMA or national scientific Advice, protocol assistance, FDA meetings, Health Canada meetings).
- 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.
- 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 CMC Regulatory and Intercontinental Regulatory teams
- Interaction with Regulatory Oncology/Neurology therapeutic areas and knowledge sharing
- Participates to maintaining good relationships with working partner when applicable (CROs, vendors, development partners …)
· Compliance
- Operates according to Regulatory and Ipsen SOPs
- Ensures that registration status is adequately reported in VREG (regulatory tracking tool) through data entry.
· 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.
Knowledge, abilities & experience
Education / Certifications:
· Degree (min Master 2 level) in scientific discipline (Pharmacy, Chemistry, Biological sciences)
· Knowledge of regulatory procedures in at least one region is preferred
Languages:
· Intermediate English if not mother tongue
Key Competencies Required :
- Excellent written and communication skills
- Ability to influence others and act as a team player
- Ability to demonstrate problem-solving skills and intellectual curiosity
- Strong scientific skills and interest for Oncology Disease area.
Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même
