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

-          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