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[담당업무] -Develop regulatory strategies for HNC product lifecycle, market expansion, and commercialization.
-Provide regulatory guidance to cross‑functional teams throughout development and launch.
-Ensure compliance by managing regulatory requirements, submissions, and registrations.
-Lead assessments on product classification, claims, labeling, and market access.
-Drive regulatory advocacy with authorities and industry groups.
-Identify and mitigate regulatory risks with clear action plans.
-Manage end‑to‑end regulatory projects and timelines.
-Monitor regulatory trends and share insights across regional/global RA teams.
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[근무부서 및 직급/직책]
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[자격요건] -Bachelor’s degree in Pharmacy, Life Sciences, Food Science/Technology, or related field; advanced degree preferred
-Minimum 5 years of regulatory affairs experience in pharmaceutical or food industries
-Proven success in regulatory submissions and approvals, including hands‑on experience with HFF and finished product registrations
-Strong knowledge of country‑specific regulatory guidelines and requirements
-Excellent organizational, analytical, and project management capabilities
-Strong written and verbal communication skills; Fluent in English
-Ability to perform effectively in a fast‑paced environment
-Individual contributor role with no direct reports
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