Priya Rawat Email & Phone Number

Chicago, Il, Us

Lake Forest, Illinois

Morton Grove, Illinois

Morton Grove, Illinois

• Review, maintenance, management and version control of SPL files (Structured Product Labeling) for drug listing, submissions, etc.• Understand and apply applicable labeling regulations and standards as interpreted by departmental or site procedures.• Support Managers in maintaining quality systems for labeling (part number, NDC assignment, label master index, change controls, document versioning, file management, side-by-side comparisons, etc.)• Maintain regulatory labeling system required to support product manufacture, submission maintenance, and new submissions.• Track internal/external systems to ensure labeling used is approved and current.• Prepare new and revised product labeling for generic and branded-generic drug products & OTC products• Strong interpersonal skills for cultivating effective collaboration with external suppliers (print vendors) and internal departments such as Purchasing, Sales & Marketing, Legal, Supply Chain, Quality Control, and Labeling Inspection to ensure updated labeling is ready for CCR process and implementation.• Develop and maintain regulatory expertise.• Review draft submissions to ensure accuracy and completeness.• Compile documentation into electronic folders or paper submissions.• Request and obtain documentation required for submissions.• Assist in SOP and Work Instructions development and review.• Compile and publish Annual Report