Regulatory Affairs Manager (f/m/d)

Regulatory affairs specialist at a pharmaceutical company in Ludwigshafen wanted! Are you interested? With the many benefits at our subsidiary Randstad professional solutions, such as competitive compensation and retirement plans, you certainly can't say "no". If that's the case, apply today for the available position! Here's another advantage: Applying with us is absolutely straightforward, requiring only your name, email address, and resume. People with disabilities are warmly welcomed at our company.

• 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