Regulatory Affairs Manager
Vor 7 Tagen
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 Extensive social benefits, incl. Christmas and holiday bonuses Up to 30 days vacation per year A wide range of employee benefits/perks
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Regulatory Affairs Manager
vor 9 Stunden
Frankfurt am Main, Hessen, Deutschland Merz Therapeutics VollzeitYOUR CONTRIBUTIONAs aRegulatory Affairs Manager (m/f/d) CMC, you will apply your knowledge of global regulatory quality requirements to support the approval and maintenance of medicinal products. Theposition is limited to 3 yearsand includes the following activities:Create, review, and update high-quality CMC documentation to obtain and maintain product...
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Regulatory Affairs Project Specialist
vor 4 Stunden
Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland Ecolab Life Sciences VollzeitEcolab, Purolite Resins, the world leader in resin-based separation, purification and extraction technology, is seeking aSenior Regulatory Affairs Specialist.We manufacture products which help our customers around the globe, mainly in pharmaceutical and life science sectors, with technology which are critical to safe manufacture of their products. It's an...
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Regulatory Affairs Manager
vor 2 Wochen
Alfred-Wegener-Straße , Frankfurt am Main, Deutschland Merz Therapeutics Vollzeit 60.000 € - 120.000 € pro JahrYOUR CONTRIBUTIONAs a Regulatory Affairs Manager (m/f/d) CMC, you will apply your knowledge of global regulatory quality requirements to support the approval and maintenance of medicinal products. The position is limited to 3 years and includes the following activities:Create, review, and update high-quality CMC documentation to obtain and maintain product...
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Leitung Regulatory Affairs
Vor 2 Tagen
Frankfurt am Main, Hessen, Deutschland Real VollzeitLeitung Regulatory Affairs (m/w/d)Aktuell suche ich für unseren Kunden, einen Medizintechnikhersteller im Norden Hessens, nach einer erfahrenen Führungspersönlichkeit im Bereich Regulatory Affairs (m/w/d) in unbefristeter Festanstellung.Ihre Aufgaben:Entwicklung und Umsetzung globaler ZulassungsstrategienSteuerung regulatorischer Prozesse über den...
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Regulatory Affairs Specialist Eu
Vor 2 Tagen
Frankfurt am Main, Deutschland Clinglobal Group Vollzeit**Regulatory Affairs Specialist - European Union** Clinglobal is an Animal Health Contract Research Organisation and supports our global operations in various countries. We are currently looking for a** Regulatory Affairs Specialist** based in the EU to join our growing Regulatory Affairs team at Clinglobal. This position offers the opportunity to work...
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Regulatory Affairs Project Specialist
vor 1 Woche
Monheim am Rhein, Deutschland Ecolab VollzeitEcolab, Purolite Resins, the world leader in resin-based separation, purification and extraction technology, is seeking a **Senior **Regulatory Affairs Specialist**.** We manufacture products which help our customers around the globe, mainly in pharmaceutical and life science sectors, with technology which are critical to safe manufacture of their products....
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Regulatory Affairs Project Specialist
vor 4 Stunden
Monheim am Rhein, Nordrhein-Westfalen, Deutschland Ecolab VollzeitEcolab, Purolite Resins, the world leader in resin-based separation, purification and extraction technology, is seeking a Senior Regulatory Affairs Specialist.We manufacture products which help our customers around the globe, mainly in pharmaceutical and life science sectors, with technology which are critical to safe manufacture of their products. It's an...
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Regulatory Affairs Project Specialist
vor 2 Wochen
Monheim am Rhein, Deutschland Ecolab VollzeitEcolab, Purolite Resins, the world leader in resin-based separation, purification and extraction technology, is seeking a Senior Regulatory Affairs Specialist.We manufacture products which help our customers around the globe, mainly in pharmaceutical and life science sectors, with technology which are critical to safe manufacture of their products. It's an...
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VP Regulatory Affairs
vor 2 Wochen
Frankfurt am Main, Hessen, Deutschland Park Brown International Vollzeit 120.000 € - 180.000 € pro JahrAbout the CompanyOur client is a pioneering digital assets bank, bridging the gap between traditional finance and blockchain innovation.As the bank expands its European footprint, we are seeking aVice President of Regulatory Affairsto lead the oversight and strategic direction of all regulatory, risk, and governance functions.Role OverviewTheVP Regulatory...
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Frankfurt: Head of Regulatory Affairs
Vor 6 Tagen
Frankfurt am Main, Deutschland Triga Consulting GmbH & Co KG VollzeitUnser langjähriger Kunde - ein international tätiges Pharmaunternehmen, welches sich auf die Entwicklung und Herstellung von Arzneimitteln spezialisiert hat - sucht derzeit für den Frankfurter Raum (in Kombination mit wöchentlich 2 Tagen Homeoffice) eine/n Head of Regulatory Affairs (m/w/d) **Budget**: 120.000-140.000 Euro als...
