Alternance - Global Regulatory Affairs Operations , From September 2024 at les Ulis/Boulogne-billancourt
Ipsen
- Les Ulis, Essonne
- Alternance
- Temps-plein
You will work closely with our Regulatory, Regulatory operation, System& IT team to contribute to the development and implementation of strategies to optimize the end-to-end regulatory journey and improve the efficiency of our data entry operating model.
- Collaborate with the regulatory team to understand their processes and requirements.
- Assist in conducting research and analysis to identify areas for improvement in regulatory processes and data management systems.
- Support the implementation of solutions to enhance regulatory compliance and data entry efficiency.
- Assist in testing phase & script execution before implementation of the new solutions & processes.
- Contribute to the creation and update of procedures and working instructions, and project deliverables.
- Contribute to the preparation of training materials & end users trainings
- Be an active member of the GRA Trainee Academy (specific program designed to provide a framework for the GRA 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.
- 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 in Regulatory affairs
- Knowledge in regulatory information management system
- French language fluent
- Ongoing master in life science discipline (pharmacist, life science engineer)
- Proficiency in Microsoft Office, especially Excel and PowerPoint
- Good analytical skills & organizational skills
- Good communication and interpersonal skills
- Good written and oral communication skillsProfessional English, written and oral