Regulatory Affairs

This role involves compiling, preparing, and submitting US ANDA and EU marketing authorization applications for MDI/DPI inhalation products while ensuring compliance with FDA and EU regulatory requirements. The position requires performing comprehensive regulatory evaluations, developing regulatory strategies, and providing CMC support to cross-functional teams throughout the product lifecycle. Key duties include reviewing Drug Master Files, evaluating change controls, and maintaining oversight of regulatory project milestones and submission timelines.