Regulatory Affairs Operations Expert Enteral Nutrition (m/f/d)

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Fresenius Kabi Deutschland GmbH
Munkavégzés helye

Németország

Munkaidő, foglalkoztatás jellege
- Teljes munkaidő
- Általános munkarend
Elvárások
- Angol felsőfok és
- Spanyol középfok
- 1-3 év tapasztalat
- Egyetem

Teljes munkaidő Általános munkarend

Angol felsőfok és Spanyol középfok 1-3 év tapasztalat Egyetem

Állás elmentve

A hirdetést eltávolítottuk a mentett állásai közül.

Responsibilities

Point of contact for Regulatory Affairs colleagues with focus on Latin America regarding product registrations, including guidance on responding to deficiency letters and regulatory authority inquiries
Coordination of national new product applications, line extensions as well as variations or renewals of existing products
Clarification of local registration requirements and development of regulatory strategies to support product registration processes
Preparation, review and updating of standard regulatory documentation (e.g., list of ingredients, nutrition information), as well as creation of country-specific registration documents
Collaboration with internal interfaces (Quality, Research & Development, Medical Scientific Affairs, Marketing) to ensure timely and compliant submissions
Active participation in project teams for food law evaluation and regulatory consulting in projects involving product changes, optimisations or line extensions
Continuous development of Regulatory Intelligence for the Latin American markets to stay up to date and compliant with regulatory requirements
Review and approval of labels and support in creating country-specific labels

Requirements

Completed university degree in Life Sciences, Food Chemistry, Food Technology or a comparable field
At least 8 years of professional experience in the regulatory field of the food industry, ideally with a focus on product registrations
Profound knowledge of Codex Alimentarius standards for foods for special dietary uses and EU food regulations
Fluent English skills, both written and spoken; Spanish is considered 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 a collaborative mindset
Excellent organisational and communication skills
Experience in intercultural project teams and willingness to travel

Company info

We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations.

#careerswithapurpose at Fresenius

Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever 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.