Detail-oriented and proactive Regulatory Affairs Specialist with 5 years of experience in the pharmaceutical industry, specializing in product registration, dossier preparation, regulatory submissions, and lifecycle management across local and international markets. Proven track record in interpreting and applying regulatory guidelines (including Medsafe, TGA, FDA, and ICH standards) to ensure full compliance and successful product approvals. Skilled in cross-functional collaboration with R&D, QA, manufacturing, and marketing teams to support both pre- and post-market regulatory activities. Adept at managing multiple submissions, responding to authority queries, and maintaining regulatory databases with precision. Committed to upholding the highest standards of quality, compliance, and ethical responsibility in all regulatory processes.