Description of Role and Responsibilities	The CMC Author will be able to prepare and review   market dossiers in Spanish and English   in alignment with the agreed regulatory strategies and timelines from key stakeholders.   Required Qualifications	• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.  • Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.   • Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).   • Flexibility in responding to changing priorities or dealing with unexpected events.   • Capability to handle multiple priorities and balance work to achieve business goals.  • Effective leadership, communication, and interpersonal skills.    • Ability to prioritize tasks to meet deadlines and work with team when help is needed.  • Ability to identify problems and work with team to formulate a potential course of action  • Work in collaboration across the organization and stakeholders.   •Experience in authoring   post approval submissions strategies per therapeutic area.   • Understand Latam regulations and trends   • Experience with   HA query management.     • Review submission packages against local CMC requirements for consistency and completeness     Desired Education	Bachelor's degree required  in science, engineering or related field (advanced degree preferred)  Desired Experience	4+ years of relevant experience, including research; manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products; or related fields.