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.