Regulatory Affairs Specialist - Cmc
Current• Practical experience in pharmaceutical regulation: small molecules, biological products in compliance with Latam requirements, ICH guidelines and scientific and company policies and procedures.• Communicate regulatory expectations, develop regulatory strategies (CMC) and risk assessments for new drug application (small molecues, biological) and maintenance of the life cycle in compliance with applicable regulations.• Guidance of other CMC Regulatory Affairs professionals in the preparation of specific documents for each country in compliance with current legislation.• CTD Writer: Preparation and review of CTD module 3 and module 2 (QOS) files.• Work in cooperation with regional and global regulatory sites to support the accurate and timely communication of critical information.• Communication with Regulatory Athorities: meetings, response to official letters, response to questions (query).• Project Managment for regulatory submission
