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).

- 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