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RA Operations Expert EN(m/w/x)
Description
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
Education
Work Experience
8 years
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
Tools & Technologies
Languages
English – Business Fluent
Spanish – Basic
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RA Operations Expert EN(m/w/x)
The AI Job Search Engine
Description
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
Education
Work Experience
8 years
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
Tools & Technologies
Languages
English – Business Fluent
Spanish – Basic
About the Company
Fresenius Kabi Deutschland GmbH
Industry
Healthcare
Description
Das Unternehmen repräsentiert Produkte und Dienstleistungen im Bereich Trinknahrung und Anästhetika.
- Fresenius Kabi Deutschland GmbH
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