Apprentice Regulatory Affairs, Global Regulatory Affairs Development Strategy
Alexion Pharmaceuticals
- Levallois-Perret, Hauts-de-Seine
- Stage
- Temps-plein
- During this apprenticeship in the Global regulatory affairs - Development Strategy (GRA-DS) department, you will have the opportunity to support various regulatory activities of Alexion- products in clinical stages in rare diseases indications.
- Preparation and submission of Clinical Trial Applications to worldwide Competent Authorities
- Support the answer to questions from Competent Authorities
- Participation to Clinical Trial Team meeting
- Preparation of Pediatric Investigation Plan, Orphan Drug Designation or Scientific Advice applications
- Regulatory intelligence
- Keep regulatory database up to date
- Have performed a first internship in the Industry
- Have basic knowledge and interest in clinical development
- Dynamic and able to build working relationship and collaborate with others, good team player,
- English both written and oral
- PharmD : Pharmaceuticals studies
- Master's Degree : Regulatory Affairs
- IT : microsoft pack office