Regulatory Affairs Trainee Role
The Regulatory Affairs Trainee program is a 12-month development opportunity designed to provide hands-on experience in the field of regulatory affairs.
* Prepare and submit changes to medicines terms of authorization (national procedure, MRP, DCP)
* Collaborate with regulatory authorities (INFARMED, I.P.) on process follow-ups
* Update internal databases with accurate information
* Review and approve packaging materials for compliance
* Support regulatory aspects for other departments (e.g., quality, market access, commercial, supply)
* Participate in internal projects to enhance knowledge and skills
Key Requirements:
* Master's degree in Pharmaceutical Sciences or relevant field
* Knowledge of regulatory affairs, preferably post-graduation
* Excellent English language skills - spoken and written
* Strong organizational and prioritization skills, including attention to detail
* Effective communication and interpersonal skills
* Ability to work collaboratively in a dynamic team environment
Areas of Development:
* Regulatory affairs, institutions, and applicable European and national regulations
* Scientific knowledge of therapeutic areas and respective medicines
This role presents an exciting opportunity to contribute to the development of innovative medicines and vaccines. If you share our ambition, please submit your CV in English.