Regulatory Affairs Officer - 264

Since 1993, ProductLife Group (PLG) has supported clients throughout the life sciences product lifecycle, combining local expertise with global reach and spanning more than 140 countries. 

PLG is a life sciences consulting firm providing outsourced services in the areas of regulatory affairs, quality and compliance, vigilance and medical information. Our expertise extends to both established product monitoring and innovative therapies and diagnostics. 

We are looking for a Regulatory Affairs Officer Consultant W/M to join our teams. 

Why join PLG? 

• International Company 
• Multi-Projects on various types of activity and products in pharma, cosmetics, biotech and medical 
• Large-scale projects/with internationally renowned clients 
• Upgrade skills 
• A dynamic and motivated team 

• Provide support to clients for the management of submissions and all other regulatory requests for the required/assigned territories 
• Contribute to regulatory activities carried out pre-MA (preparation of Module 1 documents for new registrations) and post-MA (LCM activities) 
• Assist in the preparation of marketing authorization applications (AMM) 
• Preparation, compilation and submission of documentation for post-MAH applications, including but not limited to Type IA, Type IB, Type II variations, renewals, MAH Transfers , etc. 
• Preparation and submission of technical/industrial site transfer requests 
• Document and track regulatory submissions and regulatory authority approval 
• Follow-up of MA requests, and response to questions from health authorities 
• Development, validation, dissemination and updating of texts relating to packaging items and product information: examination and modification of primary and secondary packaging texts, including the SmPC and the PIL. 
• National and international regulatory and scientific monitoring 

• Ensure compliance with all regulatory processes, with a view to internal and external audits 
• Use various software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data, for example Microsoft Office Suite, Veeva Vault (or comparable EDM system), LorenZ , Trackwise, PromoMat , etc. 
• Management and supply of internal and external regulatory databases
• Archiving of marketing authorization files and regulatory information