The Regulatory Affairs Associate supports the business and Regulatory Affairs team in day-to-day activities associated with the compilation and submission of regulatory submissions such as ANDAs to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Essential Functions:
With some guidance compile and complete the ANDAs with high-quality, following the regulatory guidelines and internal processes within time lines. Coordinates with external vendors for project support activities. This may include but not limited to RS statements, TSE/BSE statements, Melamine free certificates, cGMP certificates, Debarment certificates, US agent letters, DMF LoAs, Technical data sheets, and technical drawings, Quantitative compositions of colors, flavors e.t.c. Organize and maintain submission components associated with a regulatory submission electronically. This may include scanning, converting to pdf, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress e.t.c. under senior associate or managerial guidance. Screens the ANDAs against ANDA checklist to avoid screening queries. Screens the ANDAs against Refuse-to-Receive (RTR) Standards Guidance to prevent deficiencies that could result in RTR’s from the FDA. Tracks the committed timelines and follow up with the internal departments proactively for required documents. Prepare and update the road map for each assigned product with committed timeline by each department. Follow up with purchase team for DMFs and compliance to DMF review comments. Additional Responsibilities:
Work with colleagues in resolving regulatory issues and/or problems. Archive and maintain all submissions in a systematic way. Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department. Maintain current knowledge of regulations and other issues that affect products and industry. Ensure the regulatory databases are up-to-date as per the set criteria.
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