1 jobs found in Vermont

Regulatory Affairs Specialist is to execute on the global regulatory programs in accordance with current global regulations. The individual will coordinate the collection of information and documentation and compile into submissions, license renewals, periodic updates and registrations to regulatory agencies and partners worldwide. The individual will be responsible for the review of labeling, protocols, product development and manufacturing documents for compliance with regulatory requirements. Specific Responsibilities: Collect and coordinate documentation to prepare regulatory documentation packages for review and submission to regulatory agencies or to our commercial partners Compile materials for license renewals, updates and registrations Review labeling and labels for compliance with regulatory filings Review preclinical and clinical protocols and reports for compliance with GLP and GCP requirements, respectively Research regulatory issues and disseminate regulatory information to Production, QA/QC, and R&D departments and senior management Stay current on changes in regulations and agency guidance Required Qualifications: Bachelor s degree, preferably in life sciences or related field 5+ years of regulatory affairs experience International experience is a plus Strong understanding of global regulatory processes Excellent project management skills with the ability to multi-task - provided by Dice