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.