• Ensures the elaboration of high quality DRD (Marketing Authorization Application, Product variation, etc.) to obtain first pass approval in compliance with regulatory requirements.
Participates in key decision making involved in drug registration dossier elaboration.
• Ensures the updating of the registration file according to local regulations during the product life-cycle.
• Coordinates the preparation and execution of New Molecules Committee meetings.
• Participates in site Inspection visits escorting and serving as contact point between officials and site employees.
• Reviews, evaluates and authorizes changes controls related to generation and update texts for package and package insert.
• Coordinates translations of regulatory documents and dossiers
• Evaluates the impact of new regulation on the internal process and coordinates the implementation of regulatory changes
• Keeps updated legal-regulatory documentation CPP, GMPs, LoA, etc.
• Maintain professional relationships with appropriate health authorities based on science and technical expertise
• Provides regulatory and compliance knowledge to cross functional teams and keep updated on regulations and their changes.
• Supports Global Safety Area in regulatory activities related with Safety Reporting