Regulatory Affairs
- ProductLife Consulting
We offer a one-stop shop for consulting services dedicated to the life sciences
Regulatory Affairs
-

Regulatory Affairs Officer 166

004-placeholder Tunisia - Onsite - Regulatory Affairs 003-clock Permanent contract

Specific Activities and 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.

Required Education:

Bachelor’s or higher graduate degree in a science related field, or equivalent experience (university degree in Pharmacy would be a plus)

Required Experience :

Minimum 2 years of experience in Regulatory Affairs for the European Union (ideally for France) :
module 1 creation/update artwork review

Required Technical Skills:

Good computer skills and the ability to learn appropriate software Microsoft Office skills: Outlook, Word, Excel

Additional Experience and/or Skills:

Excellent organizational and interpersonal skills Ability to work well within a team Process orientated with good attention to detail Effective oral and written communication skills Sense of responsibility and meeting deadlines

Regulatory Affairs Officer 166

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