Regulatory Affairs Manager (f/m/d) (Regulatory-Affairs-Manager/in)
Randstad is one of the world's leading talent companies with theambition to be the world's most equitable and specialized talentcompany. Through our "partner for talent" corporate strategy, we find,develop and connect specialized talents with companies - worldwide,locally and always at a high speed. We build high-quality, diverse,and agile teams, while individuals can enjoy a rewarding career pathwith equitable opportunities.Randstad Professional is one of Randstad's four specializationsand focuses on the placement of specialists and managers in thefuture-oriented sectors of IT, Engineering, Life Science and Office.
- Provide support to complete product dossiers, technical files andresponses to information requests
- Coordinate and complete documents required by federal agencies,incl. maintaining complex files and electronic document managementsystems
- Work with project teams to obtain approval for company products
- Serve as the primary point of contact for federal governmentalagencies, embassies and consulates in Germany and function as centerof excellence for requests
- Gather documents from all EU facilities required for productregistration in applicable countries/regions
- Coordinate document requests for products approved via theCentralized Procedure (CP) but are manufactured in Germany
- Work directly with third party manufacturing companies to obtaindocuments
- Bachelor's degree in life science, clinical research studies orengineering, 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 withExcel, Word, Outlook, Teams, and Microsoft SharePoint tools
- Working knowledge of database management
- Knowledge on current policies and practices issued by local Germanfederal agencies
- Awareness on regulatory policies/procedures to learn and betterunderstand how the landscape of regulations develops
- Good proficiency in the English language
- Strong negotiation and communication skills as well as ability toorganize data and identify issues or gaps in documentation
- Performance-based salary package depending on qualifications andprofessional experience
- Option of permanent employment with our business partner
- Up to 30 days vacation per year
- Candid corporate culture
- A wide range of employee benefits/perks
Regulatory affairs specialist ata pharmaceutical company in Ludwigshafen wanted! Are youinterested? With the many benefits such as competitive compensationand retirement plans, you certainly can't say "no". If that'sthe case, apply today for the available position! Here's anotheradvantage: Applying with us is absolutely straightforward, requiringonly your name, email address, and resume. People with disabilitiesare warmly welcomed at our company.
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