Senior Regulatory Affairs Manager Enteral Nutrition (m/f/d)

☞ Fresenius Kabi

Aussicht: 185

Update Tag: 22-10-2024

Ort: Bad Homburg Hesse

Kategorie: Recht / Verträge

Industrie: Pharmaceutical Manufacturing

Position: Associate

Jobtyp: Full-time

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Jobinhalt

The Senior Regulatory Affairs Manager Enteral Nutrition (m/f/d) is part of the Business Unit Nutrition and responsible for the coordination of the rollout process of existing products as well as for the support of the regulatory product lifecycle management along with the continuous improvement of processes & tools. Besides, the Senior Regulatory Affairs Manager Enteral Nutrition (m/f/d) enables the placing on the market of the Enteral Nutrition product portfolio by obtaining and maintaining national product registrations in the markets based on ensuring food regulatory compliance, timeliness and consistency of registration dossiers.

Your assignments

  • Planning, strategy development & coordination of registration projects (new product applications and renewals or changes of exiting products)

  • Continuous development of RA processes, ways of working and tools incl. coordination of their implementation

  • Guide and support the RA ’Life Cycle Management, Tools & Global Growth’ group as well as the RA colleagues in the Development Centres and in the factory

  • Monitoring of the registration landscape/requirements in cooperation with the regions and market units

  • Planning and tracking of activities and support for local registrations

  • Contact person regarding deadlines and status of product registrations

  • Planning and coordination of the budget for registration activities

Your profile

  • Successfully completed university degree in the field of food chemistry, food science, food technology or food law

  • At least 8 years of professional experience with product registrations and regulatory projects in the food sector

  • Expert knowledge of food law (national/EU/Codex), especially for Food for Specific Groups and Food Supplements

  • Experience in association work

  • Experience in a team leader role desirable

  • Very good IT skills in MS Office (Excel, PowerPoint, Word, Outlook) and competent handling of databases and document management systems

  • Fluent in English (spoken and written), German and any other language would be beneficial
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Frist: 06-12-2024

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