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 - Registration and compilation of information to ensure regulatory compliance of products and post approval activities. - Assist with registration of products with authority and any problem solving withal governmental and nongovernmental organization. - Ensures compliance of products with the current regulations in country and across the region. - Maintain database with information on registration status of product portfolio. - Ensure that the content, organization and overall quality of all regulatory documents and samples are adequate and complies with local/regional regulatory requirements, commitments and agreements. - Maintain database with information on national regulatory requirements per country. - Have regular contact with RA Manager to discuss regulatory issues and updates. - Continuously update and advise RA manager of any changes in regulations