Mobina Shams

• Led end-to-end communication with international contractors and API suppliers across China, Europe, and India, aligning stakeholders on technical and commercial requirements that contributed to project proposal approval
• Directed supplier discussions and sourcing strategy, gaining hands-on exposure to API pricing dynamics, MOQ negotiations, and lead time optimization within a regulated pharmace

• Supported preparation of a turnkey proposal for a GMP-compliant injectable antibiotics manufacturing site, coordinating timelines, technical documentation, and cross-functional execution
• Contributed to market research and competitive analysis across antibiotic lines and injectable molecules, translating findings into portfolio recommendations to optimize projected revenue and ROI

• Authored and submitted 2 Drug Master Files (DMFs) in eCTD format ensuring 100% compliance with Health Canada and FDA regulatory standards
• Collaborated cross-functionally with Analytical Development, Formulation, and QA teams to ensure alignment of CMC documentation with product development and regulatory strategy
• Consolidated and reviewed technical data to support regulatory submissions, de

• Created tailored lesson plans and delivered interactive instruction to 62 English learners across Iran
• Increased student engagement and enhanced language proficiency through the implementation of the Inlingua intensive speaking method, advancing students from A1 to B2 levels with accelerated progress