The Acquisition of Pharma IT Will Enable PLG to Strengthen its Foothold in Northern Europe and Offer New Services in the Context of Life Sciences Digitilisation
To contribute to the production of client administrative documents to be included in regulatory submissions in Eurasia region
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
Bachelor’s degree in a science related field, or A levels with data entry experience
Experience
Experience of 1-3 years of RA experience in the pharmaceutical or service industry
Knowledge in EU regulations
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
Good computer skills and the ability to learn appropriate software
Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
Good English Language and grammar skills (written fluency a must, verbal fluency preferred)