Regulatory Affairs Manager Enteral Nutrition (m/f)

61348 Bad Homburg
16.04.2018

Daten dieser Anzeige

Job-ID: 007624037
Regulatory Affairs Manager Enteral Nutrition (m/f)

Fresenius Kabi Deutschland GmbH

Germany

https://karriere.fresenius.de/de/job_application/1963470/apply

Ensure compliance of product composition, labelling and communications with relevant EU regulations, internal procedures and codes of practice around enteral nutrition products Lead global and regional registration projects within our international network Create and maintain registration dossiers for submission Process deficiency letters or authority's inquiries and assure on-time response Provide up-date and overview of new regulation/ requirement and set up impact analysis Regulatory representation/ liaison within industry and professional associations Involvement in the regulation development at relevant authorities via the associations Develop jointly global regulatory strategies Coordinate and manage external service providers for regulatory projects and support Update standard operation procedures (SOPs) and introduce new procedures where appropriate Substitution of the Director Regulatory Affairs with respect to regulatory relevant projects

  / CAREER WITH A PURPOSE / Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. Regulatory Affairs Manager Enteral Nutrition(m/f) Being Regulatory Affairs Manager (m/f) at our location in Bad Homburg/ Germany, you are responsible for maintaining regulatory compliance of the Enteral Nutrition portfolio and lead global and regional registration projects within our international network. Become part of Fresenius Kabi and share with us our success story! We look forward to receiving your application! More Being Regulatory Affairs Manager (m/f) at our location in Bad Homburg/ Germany, you are responsible for maintaining regulatory compliance of the Enteral Nutrition portfolio and lead global and regional registration projects within our international network. Become part of Fresenius Kabi and share with us our success story! We look forward to receiving your application! Your assignments Ensure compliance of product composition, labelling and communications with relevant EU regulations, internal procedures and codes of practice around enteral nutrition products Lead global and regional registration projects within our international network Create and maintain registration dossiers for submission Process deficiency letters or authority's inquiries and assure on-time response Provide up-date and overview of new regulation/ requirement and set up impact analysis Regulatory representation/ liaison within industry and professional associations Involvement in the regulation development at relevant authorities via the associations Develop jointly global regulatory strategies Coordinate and manage external service providers for regulatory projects and support Update standard operation procedures (SOPs) and introduce new procedures where appropriate Substitution of the Director Regulatory Affairs with respect to regulatory relevant projects Your profile University degree in a Science or Legal field 5 or more years of relevant work experience in regulatory affairs in food or healthcare Strong knowledge of regulations and guidances in the EU and of Codex Alimentarius Commission, especially those applicable for food for specific groups Experience with the regulatory aspects of ingredients, including understanding of additives & flavour legislation Experience in national or regional association working groups Experience in more than 1 country or region, preferred Experience in intercultural project teams and willingness to travel Fluent in English and German, knowledge of another foreign language desirable Solid presentation skills Ability to deliver creative ideas for change and continuous process improvement Experienced in regulatory submission tools (eCTD manager) and electronic submission pathways Sound knowledge in MS Office (Excel, PowerPoint, Word) and general affinity to work with regulatory databases and document management systems Apply now Send via email Print this page At a glance Career level: Professional Experienced Job category: Regulatory Affairs / Drug Safety Working condition: Permanent contract / Full-time Business segment: Fresenius Kabi Location: Bad Homburg / Hessen Closing date for applications: none - we look forward to your application Apply now Send via email Print this page Your contact Verena Lautenschläger Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 26518 06172 686-7198 About Fresenius Career with a purpose: Over 270,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. career.fresenius.com fresenius.com   One of Fresenius' strengths: our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility. More reasons   The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits Your contact Verena Lautenschläger Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 26518 06172 686-7198 fresenius-kabi.com Career level: Professional Experienced Job category: Regulatory Affairs / Drug Safety Working condition: Permanent contract / Full-time Business segment: Fresenius Kabi Location: Bad Homburg / Hessen Closing date for applications: none - we look forward to your application About Fresenius Over 270,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. career.fresenius.com fresenius.com One of Fresenius' strengths: our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility. More reasons The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Rechts- & Steuerwesen

Medizintechnik/ Optik

Gesundheits-/ Sozialwesen/ Medizin

Angestellter/ Fachkraft

Vollzeit

61348 Bad Homburg