کارشناس رگولاتوری

Job Description

-Oversee registration project progress and provide reporting on a regular basis to executive management to ensure timely execution of regulatory strategies to support launch activities and compliance status for maintenance projects and activities -Routine maintenance of regulatory files international regulation, guidance and standards applicable to company products -Maintain regulatory framework from ingredients on worldwide regulatory and supervising agencies, FDA, EFSA, EMEA -Participate in internal audits -Create and manage control dashboard with all the inter department regulatory requirement for product compliance, with relevant work instructions -Define the best process strategy to increase time and accuracy product regulatory compliance. -Direct and oversee the execution of Product master files -Routine maintenance of regulatory files/database and chronologies. Establish and maintain system for tracking changes in documents submitted to agencies or partners. Coordinate necessary amendments -Provide strategic direction for new product development regulatory strategies aimed at improving time to market globally -Participate in corporate meetings setting strategy for meeting changing regulatory requirements and driving projects across the operations to implement required changes efficiently and effectively -Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws -Help the company or organization meet all state, local, federal, international, and industrial regulations that apply to their products -Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advice on the submission strategy -Coordinate in research of regulatory issues and dissemination regulatory information to Production, QA, QC, R&D, Supply departments and CEO -Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process -Routine maintenance of regulatory files international regulation, guidance and standards applicable to company products -Reporting to: Technical Manager -Length of Probation Period: 2 Months -Working Hours: 9:00 a.m. – 18:00 p.m.