Description
Reporting to the Regulatory Affairs Department Manager, the **Regulatory Affairs Intern** will be assigned the following support functions for the department:
* Preparation of variation documentation (IA/IB), revalidations, deficiency letters, transfers, CPPs, etc.
* Submission of the registration dossier: collect all necessary additional information for Module 1 of the registration dossier (country-specific requirements and customer requirements) and provide support for dossier submission.
* Preparation of documentation \- Module 3\.
* Enter and maintain applicable departmental databases.
* Finalize national phases. Translation/review of technical datasheets, package leaflets, and labeling (AEMPS platform, fractionation).
**WE OFFER:**
* The opportunity to join a dynamic work environment built on trust and transparency.
* **Working hours**: To be agreed with the selected candidate (6h\-8h/day, preferably between 8:00 and 16:00).
* **Start date**: October 1, 2026.
* Internship Agreement.
* Student enrolled in the Master's Program in Pharmaceutical and Parapharmaceutical Industry or in the Master's Program in Pharmaceutical and Related Product Registration.
* Advanced level of English (spoken and written proficiency is mandatory).
* We seek responsible, motivated individuals with strong teamwork skills.