Offre Global Regulatory Affairs Apprenticeship (Oncology Therapeutic area) – Ipsen – Les Ulis (91)

Classé dans : Offres : Alternances - Apprentissages | 0

Position Title: Global Regulatory Affairs Apprenticeship – Oncology Therapeutic area

Department: Global Regulatory Affairs, Oncology team

Location: Les Ulis (91)

Reports to: Regulatoy Affairs Director

  

Objectives:

 The position offers a 12 months apprenticeship in Global Regulatory Affairs (Oncology therapeutic area) and reports to the Global Regulatory Affairs Director, Oncology.

Starting date: Sept/Oct 2019

 

  • To support global regulatory development and registration plans supporting Commercialization, both pertaining to Europe/US/Canada.
  • Take part of strategic and operational tasks/discussions for either early or late stage oncology programs.

 

Role and Responsibilities:

      • Regulatory coordination
  • Contributes to the drafting and implementation of the regulatory strategy (e.g. Regulatory Strategy Documents) for specific projects, in particular 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 Neuro/Endocrine therapeutic area 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.
      • Reporting
  • Ensures adequate reporting of his/her activities, and participates to various meetings.
  • Ensures that registration status is adequately reported in VREG (regulatory tracking tool) through data entry.
      • Regulatory Intelligence
  • Contributes to Regulatory intelligence, by tracking and analyzing the evolution of
  • regulations relating to his/her areas;
  • Informs the relevant departments and answers their questions.
      •  GRA/GRSQ active team member
  • Attend/Present at GRA knowledge sharing meetings
  • Attend/Lead monthly GRA Oncology team meetings
  • Represent GRA at Ipsen internal events (eg. Poster presentation, R&D forum …)
  • Attend Ipsen internal events (Presentations, external speakers, forums, webinars, celebrations …)

Education:

      • Competencies
  • Completed or soon to be completed Degree (min Master 2 level) in scientific discipline (Pharmacy, Chemistry, Biological sciences)
  • Knowledge of regulatory procedures in at least one region is preferred
      • Skills
  • Intermediate English if not mother tongue
  • Excellent written and communication skills.
  • Strong scientific skills and interest for Oncology area

Duration:

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

 

N’hésitez pas à postuler en mentionnant le nom de l’association, c’est une offre transmise par Boris UYTTERHOEVEN (actuellement alternant chez eux, en 6ème année de pharmacie qui ancien membre du bureau de Pharm&Cie)