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.