À propos de l’offre d’emploi

We are looking for

a Regulatory Affairs Assistant/Officer

to support the team on incoming new projects.

About us

Responsibilities

• To contribute to the production of client administrative documents to be included in regulatory submissions
• Compile regulatory dossiers in accordance with national requirements.
• Systems Management and Administration
• Document and track regulatory submissions and regulatory authority approval.
• Provide regulatory support to clients and associate companies.

• Liaise with external regulatory authorities as required.
• Provide review of packaging texts.
• Provide format review of Summary of Product Characteristics, Patient Information Leaflets and labelling (e.g. QRD compliance check).
• Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
• Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services supplied by the platform/hub
• Assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).
• Assist in the management of ProductLife Ltd’s Quality Management System.

Education

• Scientific background (Pharmacist/Bio medical etc.)

Experience

• 0-2 years of previous experience (at least internship)

Skills

• Good communication skills
• Fast learner
• Ability to develop by self-learning
• Fluent in English and French any third language would be preferred