Apprenti(e) Affaires Réglementaires

Summary / purpose of the position

The position offers a 12 months apprenticeship in Global Regulatory Affairs Oncology

• To 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).
• Participates to the coordination of the responses of questions from authorities.
• 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.