Freelance RA administrative assistant (0.3 FTE)

As a Regulatory Affairs administrative assistant, you will assist the RA Head & RA Managers in various Regulatory Affairs (RA) activities, ensuring compliance, accuracy, and efficiency in processes. Your support will be essential in managing regulatory documentation, financial tasks, and artwork processes.

Responsibilities

• Assisting the RA Manager in the Regulatory Submission Process by preparing, submitting, and following up on regulatory documents in accordance with regulatory requirements
• Supporting the preparation and maintenance of product labeling, ensuring alignment with registered files, local & EU legislation, and in-house guidelines & timelines
• Assisting in artwork change verification and translation-related activities
• Maintaining and ensuring the accuracy of document management systems and archives
• Managing finance-related activities, including PO and invoice processing, vendor setup, and procurement-related tasks
• Handling the submission and follow-up of the Certificate of Pharmaceutical Products (CPP) process
• Supporting RA Managers and Officers in the artwork process
• Ensuring timely completion of all required RA training

Your Profile

• Fluent in Dutch, French, and English
• Strong organizational and administrative management skills
• Excellent communication, diplomacy, and networking abilities
• Highly detail-oriented and deadline-driven
• A proactive and autonomous attitude with a pragmatic business mindset
• Strong IT skills, particularly with databases
• Experience in Drug Regulatory Affairs and/or the Clinical Trial environment
• Interest in the scientific, economic, and social aspects of pharmaceuticals