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
• Performance-based salary package depending on qualifications and professional 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

Über Randstad Professional

Randstad ist einer der weltweit führenden Personaldienstleister mit dem Ziel, so spezialisiert und so fair zu werden wie kein anderes Unternehmen in der Welt der Arbeit. Durch die Unternehmensstrategie „partner for talent” finden, fördern und verbinden wir spezialisierte Talente mit Unternehmen – weltweit, vor Ort und immer mit hoher Geschwindigkeit. Wir schaffen leistungsfähige, vielfältige und agile Teams und unterstützen jeden Einzelnen dabei, eine erfolgreiche Karriere mit gleichen Chancen zu erreichen.

Randstad Professional ist eine der vier Spezialisierungen von Randstad und konzentriert sich auf die Vermittlung von Fach- und Führungskräften in den Zukunftsbranchen IT, Engineering, Life Science und Office.

Aus Gründen der besseren Lesbarkeit wird bei Personenbezeichnungen und personenbezogenen Hauptwörtern in Randstad Stellenanzeigen die männliche Form verwendet. Entsprechende Begriffe gelten im Sinne der Gleichbehandlung grundsätzlich für alle Geschlechter. Die verkürzte Sprachform hat nur redaktionelle Gründe und beinhaltet keine Wertung.