Alternance - Global Regulatory Affairs

il y a 1 semaine

Les Ulis, France IPSEN Temps plein

**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 core-administrative 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 problem-solving skills and intellectual curiosity

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