RA Operations Expert EN (m/f/d) na Freseniusglobal

Your 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

Your profile:

• 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