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更新于 3月28日

International Registration Director(國際注冊總監)

2.5-4萬·13薪
  • 深圳坪山區
  • 10年以上
  • 本科
  • 全職
  • 招1人

職位描述

PIC/SWHOICHCHEMICAL DRUGSEXPORT OF DRUGS
Position Information: 1. Develop an annual registration plan based on Southeast Asia, EU, Middle East, and Western market regulations and trends, clarify quality objectives, and drive product registration with advanced project management to help the company expand into international markets. 2. Evaluate market access for target markets, lead product registration applications, and enhance the team's proficiency in the aforementioned market regulations through training. 3. Review registration varieties and SOP documents, optimize documents in line with target market regulatory dynamics, and ensure company operations are compliant. 4. Coordinate the entire process of domestic and international drug materials, accurately translate and proofread international submission documents, and efficiently communicate with target market officials to advance the registration process. 5. Track target market pharmaceutical regulations and guidelines, organize analysis, and transform them into strategic recommendations for the company to aid decision-making. 6. Assist with domestic and international quality audits, complete on-site translation, and translation of rectification reports, etc. 7. Collaborate with R&D and quality departments to participate in the full process of new product development from initiation to registration based on target market regulations. 8. Participate in supplier audits, select based on target market quality standards, and establish a dynamic management mechanism to ensure product quality. 9. Efficiently complete leadership tasks, coordinate cross-departmental work, and promote internal information flow and collaboration within the company. Job Requirements: 1. Bachelor's degree or above in a pharmaceutical-related field, with English as a working language. 2. Over eight years of experience in international drug registration, with three years of core management experience, leading to the successful registration and approval of products in Southeast Asia, EU, Middle East, and other markets. 3. Proficient in target market pharmaceuticals, skilled in regulatory research, and familiar with various application process details. 4. Have an in-depth understanding of target market-related international certification requirements, lead or participate in certification projects to ensure product compliance. 5. Capable of quickly grasping target market regulations and product dynamics, transforming them into company advantages, and leading the team to adapt to changes. 6. Familiar with the production processes and standards of the application varieties, and achieve synergy between production and registration in line with target market registration requirements. 7. Possess excellent organizational, communication, and coordination skills, guiding cross-departmental registration work, and solving complex problems.

工作地點

深圳坪山區坑梓街道金輝路11號

職位發布者

健康元海濱藥業/人力資源招聘

昨日活躍
立即溝通
公司Logo健康元藥業集團股份有限公司公司標簽
健康元藥業集團始創于1992年,總部位于深圳,在創新和高壁壘技術平臺的的雙輪驅動下,現已成為一家創新科研型的綜合醫藥集團。集團始終堅持以科技創新為戰略基點,以打造創新藥和高壁壘復雜制劑技術平臺雙輪驅動為戰略目標。目前已布局4大創新高壁壘復雜制劑研發平臺。集團旗下擁有健康元、麗珠醫藥兩家大型上市公司,20余家主要控股子公司,現有員工1.4余萬人。截至2022年底,公司資產總額357.29億元,實現營業收入171.43億元。
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