Alternance - Regulatory Affairs Cmc F/m - From
Il y a 5 mois
**Regulatory coordination**:
- Participate to the CMC regulatory strategy liaising with cross functional teams
- Check current regulations to ensure strategy is developed in alignment
- Participate to build, review and maintain CMC regulatory documentation for ongoing clinical programs (IMPD/IND)
- Participate in the authoring and reviewing phase of briefing documents for consultation with Regulatory Agencies
- Support the definition of the roadmaps build to guide the preparation of global dossier taking into account geographical specificities identified for submission to ensure dossier is in line with local regulatory requirements
- Support preparation of the strategy for response to question and participate in response authoring, review, submission and follow up
- Attend relevant project and non -project related team meetings
- Potentially present the CMC regulatory output at CMC pharmaceutical development forums
- **Compliance**:
- Operates according to Regulatory and Ipsen SOPs
- Review and update trackers
- **Regulatory Intelligence**:
- Contributes to Regulatory intelligence, by tracking and analysing the evolution of regulations relating to CMC topics;
- Informs the relevant departments and answers their questions as needed.
- **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.
**Knowledge, abilities & experience**
**Education / Certifications**:
- Degree (min Master 2 level) in scientific discipline (Pharmacy, Chemistry, Quality, Biological sciences or Engineering)
**Experience**:
- Preferred previous experience in Pharmacy, Regulatory and/or Quality
Languages:
- Intermediate English if not mother tongue
**Key Competencies Required**
- Written and communication skills
- Ability to speak-up and act as a team player
- Ability to demonstrate problem-solving skills and intellectual curiosity
- Strong scientific skills and interest for CMC area.
- Strong knowledge of Microsoft Office, especially Excel tool
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