The Senior Regulatory Manager plays a key role in leading regulatory strategy and ensuring compliance across our diverse product ecosystem, from supplements and cosmetics to diagnostic test kits and food products. Youβll lead and empower a growing Regulatory team, work collaboratively with Quality, Legal, Distribution, and Brand teams, and provide strategic oversight for regulatory readiness, audits, labeling compliance, and supplier qualification.
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The Senior Director of Regulatory Affairs will develop and execute global regulatory strategies in collaboration with key stakeholders, serving as the global regulatory lead for the multifocal motor neuropathy (MMN) program and supporting other programs as needed. You will provide expert guidance to cross-functional teams, driving global regulatory submissions, acting as primary liaison with Health Authorities, and interpreting applicable Health Authority regulations and guidance documents to ensure compliance.
Weβre seeking a Manager of Regulatory Affairs to support ARMRAβs compliance efforts across product lines, marketing, and operations. This role requires strong knowledge of dietary supplement regulations and the ability to collaborate effectively with cross-functional teams. Reporting to the Senior Director of Regulatory Affairs, youβll work closely with Marketing, Product Development, Quality Assurance, and Science teams to ensure compliance.
Supports North America Regulatory activities and ensures timely preparation and completion of technical file submissions for in vitro diagnostic devices to meet project and business needs. This role requires participating on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements, develop North America regulatory strategies plan for submission for IVD products, and assess changes to product and manufacturing processes.