Position Title: Global Regulatory Affairs Apprenticeship – Oncology Therapeutic area
Department: Global Regulatory Affairs, Oncology team
Location: Les Ulis (91)
Reports to: Regulatoy Affairs Director
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 …)
- Operates according to Regulatory and Ipsen SOPs.
- 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 …)
- 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
- Intermediate English if not mother tongue
- Excellent written and communication skills.
- Strong scientific skills and interest for Oncology area
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)