Fresenius Kabi Deutschland GmbH
Regulatory Affairs Expert Enteral Nutrition(m/w/x)
Vollzeit
Senior
Keine Angabe
Bad Homburg vor der Höhe
FR
Fresenius Kabi Deutschland GmbH2 Monate
RA Operations Expert EN(m/w/x)
Vollzeit
Senior
Keine Angabe
Bad Homburg vor der Höhe
Nejo KI-Zusammenfassung
In this role, you will be the go-to expert for Regulatory Affairs in Latin America, guiding product registrations and ensuring compliance. Your day-to-day responsibilities will involve collaborating with various teams, preparing essential documentation, and staying updated on regulatory changes.
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Anforderungen
- •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
Bachelor-Abschluss
Berufserfahrung
8 Jahre
Deine Aufgaben
- •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
Tools & Technologien
MS Office (Excel, Teams, PowerPoint, Word)Document management systemsDatabases
Sprachen
Englisch – verhandlungssicher
Spanisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Fresenius Kabi Deutschland GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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