In this role you will take on responsibilities in the Regulatory Affairs team and you will report to Regulatory Affairs Manager.
Your responsibilities will include:
• On-time filing of regulatory submissions and for post-approval maintenance of regulatory dossiers. Ensure product regulatory compliance for food supplements and food with national and EU product compliance regulations including composition, claims, labeling and product registration/notification requirements.
o Coordinate compliance review of ingredients for EMEA
o Review product packaging and product information for compliance with applicable laws
o Review marketing materials
• Collaborate with internal and external stakeholders for non-EU region
• Interacting with project teams and regulatory agencies in relation to submission and other relevant topics.
• Develop a regulatory strategy for issues which could significantly impact project timelines and costs.
• Train regulatory specialists and other departments (Marketing/Legal/Quality/…) on regulatory requirements
• Provide direction in the New Product Development process as regulatory lead
• Able to write and critically identify and escalate issues to Regulatory Manager
• Stay up-to-date and understand regulatory requirements and guidelines related to food/food supplement
• Pragmatic approach in managing projects and risk assessments
• +- 5 years in Product Regulatory Affairs for food supplements or food at EU level
• Scientific Bachelor/Master degree
• Efficient and pragmatic approach
• Ability to systemically analyze problems and propose thorough and creative solutions
• Show initiative and ownership
• Eye for detail
• Excellent English skills, both written and verbal. Every additional language is considered a plus
• Able to adapt in a fast-paced setting with evolving goals and objectives
• Excellent organizational skills and ability to multitask
• Team player
A challenging opportunity in a dynamic company where you will work close to the business, have international contacts and have exposure to other departments, and where you are able to contribute to the development of a successful team.
For further information, call Laura Schollen: 016 309 509