Apprenti GRA Oncologie

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

- 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.