Senior Executive, Regulatory Affairs

A highly detail-oriented Regulatory Affairs professional specializing in Chemistry, Manufacturing & Controls (CMC), responsible for preparing, reviewing, and submitting high-quality regulatory dossiers including INDs, NDAs, ANDAs, and associated amendments to the US FDA. Ensures all submissions are completed within defined timelines while maintaining compliance with applicable regulatory guidelines and federal requirements. Demonstrates strong expertise in compiling and managing documentation for pre-development and pre-IND/NDA meeting packages, supporting strategic regulatory interactions with health authorities. Possesses hands-on experience in both pre-approval and post-approval regulatory activities for Complex Product (including Sterile, Nasal, Transdermal & Topical Dosage Forms). Exposure to EU and Canadian dossier submissions is considered an added advantage but is not essential.