Inserat online seit: 5 Mai
Aufgaben der Stelle
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
