Manager Regulatory Affair at Capgemini Engineering coordinating activities for the US market. Preparing submissions to the FDA and collaborating with internal teams for regulatory compliance.
About the role
- Compliance Manager overseeing regulatory compliance of dietary supplements in a dynamic E-commerce firm. Leading product registrations, audits, and compliance processes while supporting international expansion.
Responsibilities
- You ensure the complete legal compliance of all dietary supplements (national and EU-wide)
- You coordinate as the central interface (product management, graphics, Amazon, law firms/authorities) and act as the internal contact for all compliance topics, including Amazon and EPR
- You coordinate product registrations (EU/UK), maintain the compliance database, manage external communications and lead the compliance review prior to product launches, as well as the registration of new products with German authorities (including handling objections)
- You review and approve labels, claims, ingredient lists and translations
- You ensure health claims (EU Regulation 1924/2006) and provide the final approval for Amazon product texts
- You maintain product certificates and support audits and authority inquiries
- You handle and monitor all compliance cases in Seller Central
- You maintain compliance documentation and act as the central point of contact for Amazon Legal and Product Safety teams
- You register products with national authorities, coordinate laboratory analyses and review reports/ingredients to ensure product conformity (including GPSR)
- You maintain all annual reports and proof-of-compliance obligations
- You are responsible for and manage all EPR processes (registration, licensing, reporting) for packaging, WEEE and batteries, ensuring the general marketability of the products
- You review PZN obligations and secure pharmacy approvals
- You ensure compliance of new sales channels and act as the central interface to Quality and Supply Chain for formulation changes
- Furthermore, you drive international expansion by preparing the compliance structure for new markets, building scalable registration processes and implementing additional compliance measures to strengthen corporate conformity.
Requirements
- Degree in a natural science, pharmacy, medicine or a comparable relevant field
- Ideally at least 2 years of professional experience in the regulatory environment of the food industry
- Solid knowledge of German and European food law (composition, labelling, presentation and advertising)
- Knowledge of Codex Alimentarius standards is desirable
- Proven experience leading product launch projects while meeting all regulatory deadlines
- Proven experience in professional interaction and communication with supervisory authorities and regulatory agencies
- Excellent user skills in the Office 365 suite and confident use of relevant databases and document management systems
- Strong comprehension and analytical thinking to quickly grasp complex issues
- Precise, thorough and results-oriented working style, even under time pressure, combined with a strong quality awareness
- Excellent communication and presentation skills in German and English
- You are a strong team player with a high willingness to cooperate.
Benefits
- An engaged, motivated team with flat hierarchies in a fast-growing, future-oriented company
- Short decision-making processes, plenty of scope for creativity and responsibility
- Development opportunities and clear career perspectives within the company
- Attractive employee discounts across the entire product range
- Exciting team events to strengthen team spirit
Job title
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Not specified
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