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Alternance - Regulatory Affairs Rare Diseases (M/F)

Il y a 4 mois

Les Ulis, France IPSEN Temps plein

**Title**:
Alternance - Regulatory Affairs Rare Diseases M/F

**Company**:
Ipsen Innovation (SAS)

IpsenTraineeSquad

Ipsen is pleased to open a **12-month apprenticeship **(alternance) in the Global Regulatory Affairs, Rare Disease team We are looking for a motivated **Regulatory Affairs student** **to work in our R&D office in **Les Ulis**, France.
- 12 months apprenticeship - weekly schedule can be flexible and discussed during interview

**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 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 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.

**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.

**EHS Missions**
- Respect the regulations and EHS procedures in force.
- Participate in the EHS performance of the site by reporting risks, malfunctions or improvements.
- Participate in mandatory EHS training.

Education / Certifications:

- Degree (min Master 2 level) in scientific discipline (Pharmacy, Chemistry, Biological sciences)
- Knowledge of regulatory procedures in at least one region is preferred

Languages:

- Intermediate English if not mother tongue

Key Competencies Required
- Excellent written and communication skills
- Ability to influence others and act as a team player
- Ability to demonstrate problem-solving skills and intellectual curiosity
- Strong scientific skills and interest for Rare Disease area.