Regulatory affairs specialist at a pharmaceutical company in Ludwigshafen wanted! Are you interested? With the many benefits we offer, 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.
Here's what we offer
1. Performance-based salary package depending on qualifications and professional experience
2. Option of permanent employment with our business partner
3. Extensive social benefits, incl. Christmas and holiday bonuses
4. Up to 30 days vacation per year
5. A wide range of employee benefits/perks
Your tasks
6. Provide support to complete product dossiers, technical files and responses to information requests
7. Coordinate and complete documents required by federal agencies, incl. maintaining complex files and electronic document management systems
8. Work with project teams to obtain approval for company products
9. Serve as the primary point of contact for federal governmental agencies, embassies and consulates in Germany and function as center of excellence for requests
10. Gather documents from all EU facilities required for product registration in applicable countries/regions
11. Coordinate document requests for products approved via the Centralized Procedure (CP) but are manufactured in Germany
12. Work directly with third party manufacturing companies to obtain documents
Your profile
13. Bachelor's degree in life science, clinical research studies or engineering, ideally with previous regulatory experience
14. Several years of experience in a regulated business environment (e.g. legal office, regulated industry)
15. Experience working with Microsoft Office suite, most notably with Excel, Word, Outlook, Teams, and Microsoft SharePoint tools
16. Working knowledge of database management
17. Knowledge on current policies and practices issued by local German federal agencies
18. Awareness on regulatory policies/procedures to learn and better understand how the landscape of regulations develops
19. Good proficiency in the English language
20. Strong negotiation and communication skills as well as ability to organize data and identify issues or gaps in documentation