Alternance - Regulatory Affairs Rare Diseases (M/F) - Les Ulis, France - IPSEN

IPSEN
IPSEN
Entreprise vérifiée
Les Ulis, France

il y a 1 semaine

Sophie Dupont

Posté par:

Sophie Dupont

beBee Recruiter
Description

Title:

Alternance - Regulatory Affairs Rare Diseases M/F


Company:

Ipsen Innovation (SAS)

IpsenTraineeSquad


Ipsen is pleased to open a
12-month apprenticeship (alternance) in the Global Regulatory Affairs, Rare Disease team We are looking for a motivated
Regulatory Affairs student
to work in our R&D office in Les Ulis**, France.


  • 12 months apprenticeship weekly schedule can be flexible and discussed during interview

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 coreadministrative 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.

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 problemsolving skills and intellectual curiosity
  • Strong scientific skills and interest for Rare Disease area.
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