Alternant - Cmc Regulatory Strategy, Innovative Biotech Products F/m , From September 2025, Paris

il y a 19 heures

Paris, France Ipsen Innovation (SAS) Temps plein

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

LI-Hybrid

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