Commercial Operations & US-Regulatory Manager (m/f/d)

As US Market Operations & Regulatory Lead, you are responsible for the operational and regulatory preparation of the US market entry. You ensure that our products are FDA-compliant, import-ready, and market-ready while coordinating all relevant processes between Europe and the United States. You act as the central interface between Product Development, Supply Chain, Marketing, Operations, external partners, and US service providers, ensuring that products can be launched into the US market efficiently, compliantly, and in a scalable manner. In this role, you take on not only coordination tasks but also true operational ownership for execution and problem-solving.

• Responsible for the regulatory preparation of the US market entry.
• Ensure compliance with all relevant FDA, regulatory, and import requirements for dietary supplements, functional food, and sports nutrition products.
• Lead and coordinate all FDA-related processes.
• Review product formulations, ingredients, functional claims, health claims, packaging, labeling, Nutrition Panels / Supplement Facts, and coordinate regulatory documentation, import requirements, and approval processes.
• Support the development of FSVP and compliance structures.
• Monitor regulatory changes within the US market and translate them into operational actions.
• Collaborate closely with external consultants, laboratories, authorities, and FDA/import partners.

• Manage customs brokers, freight forwarders, and US warehousing partners.
• Oversee Prior Notice processes and import documentation.
• Support duties & tariffs management, port operations, FDA holds, container coordination, and warehousing processes.
• Ensure smooth product imports and operational market readiness.
• Independently resolve operational and regulatory challenges.

• Prepare products and processes for distributor and retail requirements.
• Coordinate packaging specifications, case dimensions, pallet standards, vendor requirements, and compliance documentation.
• Ensure full commercial readiness of new products.

• Support the development of the operational US infrastructure, including Importer of Record structures, product liability insurance, recall procedures, state registrations, compliance documentation, and operational processes.
• Establish efficient processes and workflows for international expansion.
• Monitor timelines, risks, and dependencies.

• Act as the operational interface between the European organization and US market requirements.
• Translate regulatory and operational requirements between both markets.
• Ensure realistic timelines and adherence to US go-to-market standards.
• Work closely with Product Development, Supply Chain, Marketing, and Sales teams.
• Coordinate internal alignment processes across multiple departments.

• Experience in Regulatory Affairs, Commercial Operations, Import Operations, or International Expansion.
• Experience within the supplements, sports nutrition, functional food, beverage, FMCG, or consumer health industries.
•  Strong understanding of US regulatory requirements, including FDA regulations, dietary supplements, import regulations, labeling, and claims compliance.
•  Hands-on experience with FDA, import, or customs processes is required.
•  Highly structured and solution-oriented working style.
•  Strong project management and organizational skills.
•  Ability to manage operational and regulatory topics simultaneously.
•  High level of ownership combined with a hands-on mentality.
•  Excellent written and spoken English skills.
•  Ability to work pragmatically and efficiently in a fast-paced, dynamic environment.