Alternance - Global Regulatory Affairs - 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 - Global Regulatory Affairs, Neurosciences M/F


Company:

Ipsen Innovation (SAS)

IpsenTraineeSquad


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


Main responsibilities / job expectations

Regulatory coordination

  • Strong collaboration with Business, Medical, Safety and industrial teams to support the development and expansion of the products
  • Ensures adequate planning and timelines management/adjustment depending on the deliverable
  • Contributes to critical and constructive review of regulatory dossiers (New registrations, Renewals, Variations)
  • Works on the content of regulatory submission dossiers
  • Supports the coordination of the preparation with relevant functions and the assembly of regulatory documentation to be submitted according to the strategy validated
  • Ensures quality authoring of coreadministrative parts of submission packages
  • Ensures adequate coordination of regulatory activities through reliable liaison with LRAs.
  • Participates to the coordination of the responses of questions from authorities
  • Support Intercontinental regions in case of questions / update of dossier
  • Update Regulatory Database (VReg) and Regulatory tools and trackers.

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.

Compliance

  • Operates according to Regulatory and Ipsen SOPs

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.

Knowledge, abilities & experience

Competencies

  • Degree (min Master 2 level) in scientific discipline (Pharmacy, Chemistry, Biological sciences)
  • Knowledge of regulatory procedures

Skills

  • Intermediate English if not mother tongue
  • Excellent written and verbal communication skills
  • Strong critical thinking skills.
  • Ability to work on various projects
  • Ability to demonstrate problemsolving skills and intellectual curiosity
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