Dedicated and skilled Regulatory Affairs professional with over 7 years of experience in dossier submissions, query handling, and managing post-approval changes across diverse markets including Europe, Australia, and the Rest of the World. Proficient in CMC document authoring and review, regulatory assessments, and utilizing regulatory software such as Veeva RIMS and DXC eCTD. Adept at coordinating with cross-functional teams to ensure compliance and timely submissions.