Regulatory Affairs Manager (f/m/d)

Ihr Ansprechpartner

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: 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.

Das bieten wir Ihnen

• Option of permanent employment with our business partner
• Extensive social benefits, incl. Christmas and holiday bonuses
• Up to 30 days vacation per year
• Free online courses

Ihre Aufgaben

• Provide support to complete product dossiers, technical files and responses to information requests required in order to market products internationally
• Coordinate and complete documents required by federal agencies, maintaining complex files and electronic document management systems and work with project teams to obtain approval for company products
• Execute tasks and exercise influence generally at the middle management level
• In alignment with the overarching global regulatory strategy and in close collaboration with the Area and Affiliate Strategy regulatory team, this position serves as the primary interface with the affiliates to coordinate and complete international regulatory documents and samples in order to register and market products internationally
• Serve as the primary point of contact with federal governmental agencies, embassies and consulates in Germany and center of excellence for requests related to all products with manufacturing licenses or that are released within the EU marketplace
• Gather documents from all EU facilities required for product registration in applicable country/region
• 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

Ihr Profil

• Bachelor's degree in life science, clinical research studies or engineering
• Previous regulatory experience is preferred
• Several years of experience in a regulated business environment (e.g. legal office, regulated industry)
• Good knowledge of English language
• Developed negotiation skills for interactions with governmental agencies
• Ability to organize data and identify issues or gaps in documentation and the ability to effectively communicate in oral and written forms
• Experience with Microsoft Office suite, most notably with Excel, Word, Outlook, Teams
• Working knowledge of Database management
• Experience with Microsoft SharePoint tools and ability to navigate and update documents within SharePoint site
• Continued knowledge on current policies and practices issued by local German federal agencies for completion of document requests and legalization requirements
• Maintain active awareness on regulatory policies/procedures to learn and better understand how the landscape of regulations changes from time to time