Back to jobsPrepare, submit, and maintain U.S. product registration dossiers, including new registrations, label amendments, renewals, and associated regulatory activities.
Develop and implement regulatory submission strategies in collaboration with technical, marketing, and cross‑functional teams to support commercial objectives.
Serve as the primary regulatory liaison with internal departments, regulatory authorities, consultants, and global team members to troubleshoot issues and expedite project timelines.
Coordinate the development, compilation, review, and maintenance of technical documentation, including product labels, supporting literature, and registration dossiers.
Collaborate with global and regional stakeholders to develop and maintain data dossiers for existing and new products.
Evaluate and provide regulatory guidance on raw materials, formulation changes, and product modifications to ensure regulatory compliance and product conformity.
Monitor regulatory compliance throughout the product lifecycle, from development through commercialization, and support internal audits as required.
Conduct regulatory research to interpret evolving requirements and apply findings to submission strategies and compliance activities.
Maintain accurate and current regulatory databases, records, and filing systems in accordance with internal and regulatory requirements.
Uphold strict confidentiality of company business information and regulatory data.
Participate in regulatory training, continuous improvement initiatives, and professional development activities.
Perform other related regulatory or administrative tasks as assigned.