Regulatory Affairs Manager (f/m/d)

Regulatory affairs specialist 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 at a pharmaceutical company! 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.

Here's what we offer

• Extensive social benefits, including Christmas and holiday bonuses
• Option of permanent employment with our business partner
• Free online courses
• Up to 30 days vacation per year
• Support in completing product dossiers, technical files, and responses to information requests for international product marketing
• Coordinate and complete documents required by federal agencies, maintain complex files and electronic document management systems, and work with project teams to obtain product approval
• Execute tasks and exercise influence at the middle management level
• Serve as the primary interface with affiliates to coordinate and complete international regulatory documents and samples for product registration and marketing
• Act as the primary contact with federal agencies, embassies, and consulates in Germany for products with manufacturing licenses or released within the EU
• Gather documents from EU facilities for product registration in applicable regions
• Coordinate document requests for products approved via the Centralized Procedure (CP) manufactured in Germany
• Work directly with third-party manufacturers to obtain necessary documents

Your profile

• Bachelor's degree in life sciences, clinical research, or engineering
• Previous regulatory experience preferred
• Several years of experience in a regulated industry or legal environment
• Proficiency in English
• Strong negotiation skills for interactions with government agencies
• Ability to organize data, identify documentation gaps, and communicate effectively orally and in writing
• Proficiency with Microsoft Office, especially Excel, Word, Outlook, Teams
• Experience with database management
• Familiarity with Microsoft SharePoint for document navigation and updates
• Knowledge of current policies and practices of German federal agencies regarding document legalization
• Ongoing awareness of regulatory policy changes and landscape