Regulatory Affairs Junior Associate

Global Responsability
Compile and manage the Registration dossiers or the Variation packages for submission and follow up until product approval and launch, or change implementation. Organize regulatory information, logs and tracking. 

Specific Responsibilities

• To stay updated on changes in legislation and regulations and advises and gives interpretation on the potential impact to the product registration, marketing, manufacturing or development.
•  Compilation of required information for registration dossiers, variations, renewals according to European legislation or non-European countries.
• Registration submission and follow up with Health Authorities and Licensees, until product approval and launch.
• Coordination and preparation of Answers to deficiencies letters received from Health Authorities.
• Maintains regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or licensees.
• Coordinate and manages national phases for each procedure (new registrations, variations and renewals)
• Prepare and reviews product labelling for compliance with regulatory requirements (spc, label, leaflet and cartoon boxes)

Requirements and personal skills

• Education: University Degree in live science (Veterinary, Pharmacy, Biology or Chemistry). Master is a plus.
• Languages: High level of English is a must; Knowledge of other European language is also a plus.
• Experience (years/area): 1-3 years of experience required.
• Specific Knowledge: Very good knowledge of general pharmaceutical legislation and regulations and registration dossier format content.  Proficiency with standard software tools (Word, Excel, PowerPoint, etc.).
• Travels: Ocasionally
• Personal skills: good communication skills, Teamwork, results-oriented, Autonomous