Position Overview
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Act as Regulatory Affairs authority for key product registrations with a main focus in labeling and labeling related activities.
Analyze and determine worldwide product registration requirements for specific assigned products and regions. Implement worldwide regulatory registration strategy, communicate and negotiate with local market authorization holders/ distributors / regulatory authorities the information required and prepare regulatory submissions to be used worldwide for all marketed products.
Prepare complex registration dossiers, local application forms; negotiate documentation required for worldwide markets which may include product custom clearance documentation and coordinate with International Customer Service, Quality and Commercial preparation of required documentation in accordance with local requirements.
Prepare responses to regulatory agency inquiries.
Coordinate with local authorities and Quality standards and...