ROLE
– Compile, prepare, review, and submit high-quality US ANDA and EU marketing authorization applications
– Perform comprehensive regulatory evaluations of assigned drug products
– Prepare Controlled Correspondence submissions and pre-ANDA meeting packages for CMC-related topics
– Conduct regulatory assessments of master formula clearance, IIG clearance, device sameness, product specifications, stability protocols, scientific literature, FDA guidance and resources, and other CMC documentation
– Actively participate in cross-functional team meetings and discussions with device suppliers
– Ensure that final US ANDA and EU submissions comply with the latest US FDA ANDA Checklist, EU regulatory requirements, and applicable guidance documents
– Develop and implement regulatory strategies for MDI/DPI inhalation products
– Evaluate Change Controls from a Regulatory Affairs perspective
– Maintain comprehensive oversight of all regulatory activities for assigned projects