Description. Oversee regulatory support and compliance in accordance with guidelines from USDA, FDA, and international regulatory agencies. Responsibilities will be related to new product development and the management of controlled documents. Communicate with government agencies (such as USDA and FDA) and current or potential business partners regarding regulatory matters. Provide necessary documentation to distribution partners and internationa...
Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world. JOB SUMMARY. The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. A Senior Associate is expected to have a stron...
Purpose. . The Senior Regulatory Affairs Associate is responsible for assessing and ensuring regulatory compliance of the quality management system. Development of regulatory documents. planning, tracking, execution, and archival of regulatory submissions. performing regulatory landscape. and regulatory affairs project management in support of designated activities. Duties & Responsibilities. . Generate audit agenda, plan, summary report, and per...
Senior Regulatory Affairs Associate. Experience: Biologic CMC. 5 years of experience. Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to. new application, post approval variations. Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appropriate standards & requirements. Experienced in CTD update/authoring (...
