GRA Onco Apprentice (H/F)

Title:

GRA Onco Apprentice (H/F)

Company:

Ipsen Innovation (SAS)

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

• 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

#LI-Hybrid
#IpsenTraineeSquad

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.