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Regulatory Documentation Specialist The candidate will be responsible for the support and maintenance of the regulatory management database which includes to: evaluation of registration requirements for global product registration, implementation of standard operating procedures (SOPs) established by the department manager, handling of inter/intradepartmental inquiries, managing product registrations per assigned region and contributing to the departments goals and project milestones. Manage product registration globally via various activities including but not limited to requesting, procuring, processing and preparing appropriate documentation, documenting and tracking progress of new registrations and re-registrations in each market. Ensure that progress is in line with the company's targets. Collect and maintain files necessary to define product registration, re-registration and import processes. Timely distribution of latest version documents to all appropriate users. Maintain a computer database of all filed documentation that ensures fast retrieval of documents. Perform clerical typing duties to generate documents as necessary. Identify unique regulatory requirements in new and existing markets and assess the impact of such requirements on manufacturing, product development and the business. Alert upper management and relevant partners to the impact. Anticipate future regulatory challenges with similar impact. Identity regulatory challenges that may arise as a result of new initiatives and new product launches by the company; propose approaches to successfully work through these challenges to ensure the company goals are met. Build and foster strong working relationships with departments within and outside the firm including franchisees, government agencies (USDA, South Carolina Department of Agriculture, Department of State, etc.,) and manufacturing partners. Facilitate the exchange of documents and technical conversations to support registration. Keep abreast of regulatory changes or proposed changes that may impact product formulation, product manufacture and/or product registration. Provide franchisees the necessary support to interact with local authorities in order to support or defend against proposed regulations. Create and Manage monthly registration reports with global franchisees to ensure reports are transmitted to firm (i.e. registrations, re-registrations and regulations). Represent firm at regulatory meetings/conferences as needed. 2+ years of relevant experience or experience as a paralegal preferred. Familiarity with the FDAs Code of Federal Regulations 21 CFR 111 and 101 a plus. Bachelor's Degree required in a related field such as chemistry, law, biochemistry, quality control, food science is essential.
Req. Number: 2018-56615
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