Regulatory Affairs Manager (f/m/d)

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