Time for change – time for a new job! You are a regulatory affairs specialist and looking for a new professional challenge? Then stop searching! We offer the job you are looking for: Our subsidiary Randstad professional solutions offers a secure job, fair compensation and exciting new tasks at an attractive pharmaceutical company in Ludwigshafen. Apply online now! We welcome applications from all suitably qualified persons regardless of any disabilities.
* Provide support to complete product dossiers, technical files and responses to information requests
* Coordinate and complete documents required by federal agencies, incl. maintaining complex files and electronic document management systems
* Work with project teams to obtain approval for company products
* Serve as the primary point of contact for federal governmental agencies, embassies and consulates in Germany and function as center of excellence for requests
* Gather documents from all EU facilities required for product registration in applicable countries/regions
* Coordinate document requests for products approved via the Centralized Procedure (CP) but are manufactured in Germany
* Work directly with third party manufacturing companies to obtain documents
* Bachelor's degree in life science, clinical research studies or engineering, ideally with previous regulatory experience
* Several years of experience in a regulated business environment (e.g. legal office, regulated industry)
* Experience working with Microsoft Office suite, most notably with Excel, Word, Outlook, Teams, and Microsoft SharePoint tools
* Working knowledge of database management
* Knowledge on current policies and practices issued by local German federal agencies
* Awareness on regulatory policies/procedures to learn and better understand how the landscape of regulations develops
* Good proficiency in the English language
* Strong negotiation and communication skills as well as ability to organize data and identify issues or gaps in documentation
* Above-average salary
* Extensive social benefits, incl. Christmas and holiday bonuses
* Up to 30 days vacation per year
* Company pension scheme contribution after the end of the probationary period
* A wide range of employee benefits/perks