The position offers a 12 months apprenticeship in Global Regulatory Affairs, TA (oncology, neurology or rare disease)

- 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

• 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 marketing authorization procedures with support from GRA Director and Local Regulatory Affairs (LRAs) 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.
  • Strong collaboration with CMC Regulatory/ Regulatory excellence and Regulatory operations
  • 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.

•  GRA and GRA Trainee Academy active team member
  • Attend/Present at GRA 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 GRA 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.

• Key technical competencies
  • Excellent written and oral communication skills and delivers all communication with clarity and impact.
  • Ability to influence others and act as a team player
  • Ability to demonstrate problem-solving skills and intellectual curiosity