PRODUCTLIFE GROUP recrutement – CTA Submission Officer – Tunis

Responsibilitie

• Assist in drafting  and updating key documents
• Perform updates when new regulation or new practical information becomes available.
• Consult the systems for the clinical study pre-requisites in each country.
• Prepare core documentation for Clinical Trial Application (CTA).
• Liaise with concerned authorities about administrative questions, in order be within expected timelines.
• Amendment File preparation
• In  charge  of  updating  the  information  registered  in main public registries, in accordance with instructions provided in the corresponding quality document (linked to clinical trials).
• Involved  in  redaction  of  regulatory  sections .
• Notification to the ANSM of New Event/Urgent Safety Measure
• Retrieves the  anonymized CT synopsis  and  the  lay  summary,  and is  in  charge  of  initiating  the  publication  of  results documents in  the  website back office, including their upload.
• Enters  the  date  of  publication of  documents linked to clinical trials in  the dedicated tracking table.
• Manage achievement steps for submission of CT report synopsis to countries.
• Participate in the preparation of any inspection relating to a CT
• In  charge  of  training  the  employees  to  European  CT  Regulation

• Bachelor’s degree in life Science/ Pharmacy related field

Experience

• Min 1 year of experience in Regulatory Affairs/ Pharmacist
• CTA Worldwide knowledge (Japan, China, India, Canada)
• Monitoring clinical research
• Protocol creation

• Fluent in English/ French (written &spoken)
• Excellent attention to detail
• Ability to work well within a team
• Good time management skills
• Ability to work to tight deadlines
• Process oriented
• Excellent communication skills