The position offers a 12-month apprenticeship in Global Regulatory Affairs, CMC Regulatory strategy, Biological products and reports to the Senior Director, Senior Manager or Manager in GRA CMC Regulatory Strategy.
Here are your responsabilities:
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 and follow-up 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.
Educational Background
A bachelor's or master's degree in life sciences, pharmacy, chemistry, biotechnology, or chemical engineering, regulatory science or pharmaceutical sciences.
Language Skills:
Proficiency in English
Key Soft Skills
Attention to detail, Communication skills, Analytical Thinking, Problem-Solving, Teamwork and Collaboration
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