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Fresenius Kabi Deutschland GmbH
3mo ago

RA Operations Expert EN(m/w/x)

Bad Homburg vor der Höhe
Full-timeOn-siteSenior

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.

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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

Bachelor's degree

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

MS Office (Excel, Teams, PowerPoint, Word)Document management systemsDatabases

Languages

EnglishBusiness Fluent

SpanishBasic

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