Fresenius Kabi Deutschland GmbH
Regulatory Affairs Expert Enteral Nutrition(m/w/x)
Full-timeOn-siteSenior
Bad Homburg vor der Höhe
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FRFresenius Kabi Deutschland GmbH
RA Operations Expert EN(m/w/x)
Bad Homburg vor der Höhe
Full-timeOn-siteSenior
Nejo AI Summary
Preparing and updating regulatory documentation for nutritional drinks and anesthetics. 8 years regulatory experience in food industry, with Codex Alimentarius knowledge, required. International product registration coordination, with a focus on Latin American markets.
Requirements
- University degree in Life Sciences, Food Chemistry, Food Technology, or comparable field
- At least 8 years of professional experience in regulatory field of food industry
- Profound knowledge of Codex Alimentarius standards and EU food regulations
- Fluent English skills, both written and spoken; Spanish is an asset
- Excellent proficiency in MS Office (Excel, Teams, PowerPoint, Word)
- Confident handling of document management systems and databases
- Service-oriented and detail-focused with strong analytical thinking
- High level of quality awareness
- Affinity for working with digital systems and tools
- Strong team player with collaborative mindset
- Excellent organisational and communication skills
- Experience in intercultural project teams and willingness to travel
Tasks
- Serve as the point of contact for Regulatory Affairs colleagues in Latin America regarding product registrations
- Guide responses to deficiency letters and regulatory authority inquiries
- Coordinate national new product applications, line extensions, and renewals of existing products
- Clarify local registration requirements and develop regulatory strategies for product registration
- Prepare, review, and update standard regulatory documentation, including ingredient lists and nutrition information
- Create country-specific registration documents
- Collaborate with internal teams, including Quality, Research & Development, Medical Scientific Affairs, and Marketing, for timely and compliant submissions
- Participate in project teams for food law evaluation and regulatory consulting on product changes and optimizations
- Continuously develop Regulatory Intelligence for Latin American markets to ensure compliance with regulations
- Review and approve labels and assist in creating country-specific labels
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- Spanish – Basic
Tools & Technologies
- MS Office (Excel, Teams, PowerPoint, Word)
- Document management systems
- Databases
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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FRFresenius Kabi Deutschland GmbH
RA Operations Expert EN(m/w/x)
Bad Homburg vor der Höhe
Full-timeOn-siteSenior
Nejo AI Summary
Preparing and updating regulatory documentation for nutritional drinks and anesthetics. 8 years regulatory experience in food industry, with Codex Alimentarius knowledge, required. International product registration coordination, with a focus on Latin American markets.
Requirements
- University degree in Life Sciences, Food Chemistry, Food Technology, or comparable field
- At least 8 years of professional experience in regulatory field of food industry
- Profound knowledge of Codex Alimentarius standards and EU food regulations
- Fluent English skills, both written and spoken; Spanish is an asset
- Excellent proficiency in MS Office (Excel, Teams, PowerPoint, Word)
- Confident handling of document management systems and databases
- Service-oriented and detail-focused with strong analytical thinking
- High level of quality awareness
- Affinity for working with digital systems and tools
- Strong team player with collaborative mindset
- Excellent organisational and communication skills
- Experience in intercultural project teams and willingness to travel
Tasks
- Serve as the point of contact for Regulatory Affairs colleagues in Latin America regarding product registrations
- Guide responses to deficiency letters and regulatory authority inquiries
- Coordinate national new product applications, line extensions, and renewals of existing products
- Clarify local registration requirements and develop regulatory strategies for product registration
- Prepare, review, and update standard regulatory documentation, including ingredient lists and nutrition information
- Create country-specific registration documents
- Collaborate with internal teams, including Quality, Research & Development, Medical Scientific Affairs, and Marketing, for timely and compliant submissions
- Participate in project teams for food law evaluation and regulatory consulting on product changes and optimizations
- Continuously develop Regulatory Intelligence for Latin American markets to ensure compliance with regulations
- Review and approve labels and assist in creating country-specific labels
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- Spanish – Basic
Tools & Technologies
- MS Office (Excel, Teams, PowerPoint, Word)
- Document management systems
- Databases
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Fresenius Kabi Deutschland GmbH
Industry
Healthcare
Description
Das Unternehmen repräsentiert Produkte und Dienstleistungen im Bereich Trinknahrung und Anästhetika.
Not a perfect match?
- Fresenius Kabi Deutschland GmbH
Regulatory Affairs Expert Enteral Nutrition(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Fresenius Kabi Deutschland GmbH
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Regulatory Affairs Specialist(m/w/x)
Full-timeOn-siteExperiencedFrankfurt am Main - Fresenius Kabi Deutschland GmbH
Senior Manager Clinical Operations(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Fresenius Kabi Deutschland GmbH
Global Product Manager Enteral Nutrition & Keto(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe