Description

In this role, you will engage in cross-functional collaboration to ensure compliance with regulatory standards while supporting the development and maintenance of essential documentation for Animal Health pharmaceutical products.

Requirements

• •Minimum B.S. in pharmacy, chemistry, or science degree
• •Experience in preparing CMC sections in Common Technical Document format
• •Experience in preparing US supplements and EU variations
• •Experience critically reviewing detailed scientific information
• •Good understanding of manufacturing, analytical, quality assurance, and R&D
• •Strong written and verbal communication skills in multicultural settings
• •High level of professionalism
• •Proficient in English
• •Accountability
• •Adaptability
• •Detail-oriented
• •Mentorship
• •Project management
• •Regulatory compliance

Tasks

• •Collaborate with manufacturing, quality, technical support, and R&D teams
• •Coordinate with the main project responsible CMC AD
• •Ensure all important CMC documentation is complete
• •Support the development of standard processes for regulatory compliance
• •Participate in complex projects related to regulatory processes
• •Maintain knowledge of EMA, FDA, VICH, and country-specific CMC guidelines
• •Provide documentation for various countries and maintain submission documents
• •Assist senior team members during the LOQ-A phase by tracking progress
• •Support project activities like Gap & Risk assessments and kick-off meetings
• •Check submitted or registered status with CORAs and compile necessary variations
• •Participate in new product development teams and other project teams