職位描述
進口藥品注冊
1. Based on Pharma regulations and technical guidelines, be responsible for Marketing Authorization for drugs.
2. Collecting, updating various kinds of laws and regulations information, which are related to our products and Industry, and providing to RA Director / liner manager as useful and valid reference.
3. After establishing new products’ registration / changing registration for existing products, work out registration schedule and action-plan.
4. Finishing all registration dossiers preparation and generation (including docs searching, collection, translation, editing, integrating) and archiving. Submitting registration dossiers to authority on time and following related technical and administrative evaluation progress and answering all questions from Gov’t.
5. Based on laws and regulation requirements, work out and/or adjust relevant internal SOPs, to ensure all regulatory dossiers are fully in line with related laws and regulations.
6. Cooperating with PD, QA/QC and the 3rd party, to optimize and finalize standard research and standard establishment, furthermore, to check and confirm those finalized standard, together with their analytical/testing methods, can be implemented in future commercial production.
7. Based on SOPs, collaborating with PD, Sourcing, QA/QC, to check and confirm all raw materials (including their names, standards and suppliers, etc.) not only can fully meet relevant regulations, but also are exactly same as what are submitted and approved by authority.
8. Based on Pharma Regulation and pharmacopeia, collaborating RD/PD to develop and conduct long-term / accelerate stability studies and other technical studies, so as to meet registration purposes.
9. Responsible for CVM system review work to ensure they are fully compliant from regulation viewpoint.
10. Fully understanding relevant pharma laws/regulations, and collecting Industry information (including technology, national standard, analysis method and raw material, etc.). Adjusting and updating our pharma’s registered standards, accordingly.
11. Be responsible for relevant regulatory stakeholders’ management and maintenance.
2. Collecting, updating various kinds of laws and regulations information, which are related to our products and Industry, and providing to RA Director / liner manager as useful and valid reference.
3. After establishing new products’ registration / changing registration for existing products, work out registration schedule and action-plan.
4. Finishing all registration dossiers preparation and generation (including docs searching, collection, translation, editing, integrating) and archiving. Submitting registration dossiers to authority on time and following related technical and administrative evaluation progress and answering all questions from Gov’t.
5. Based on laws and regulation requirements, work out and/or adjust relevant internal SOPs, to ensure all regulatory dossiers are fully in line with related laws and regulations.
6. Cooperating with PD, QA/QC and the 3rd party, to optimize and finalize standard research and standard establishment, furthermore, to check and confirm those finalized standard, together with their analytical/testing methods, can be implemented in future commercial production.
7. Based on SOPs, collaborating with PD, Sourcing, QA/QC, to check and confirm all raw materials (including their names, standards and suppliers, etc.) not only can fully meet relevant regulations, but also are exactly same as what are submitted and approved by authority.
8. Based on Pharma Regulation and pharmacopeia, collaborating RD/PD to develop and conduct long-term / accelerate stability studies and other technical studies, so as to meet registration purposes.
9. Responsible for CVM system review work to ensure they are fully compliant from regulation viewpoint.
10. Fully understanding relevant pharma laws/regulations, and collecting Industry information (including technology, national standard, analysis method and raw material, etc.). Adjusting and updating our pharma’s registered standards, accordingly.
11. Be responsible for relevant regulatory stakeholders’ management and maintenance.
工作地點
浦東新區(qū)上海市浦東區(qū)嘉里城辦公樓
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職位發(fā)布者
呂雪景/人事經(jīng)理
今日活躍立即溝通
達能亞太(上海)管理有限公司達能集團，總部設(shè)立于法國巴黎，全球擁有近7萬5千名員工，是世界著名的食品和飲料集團之一。達能集團歷史悠久，規(guī)模強大，位列世界500強，業(yè)務(wù)遍及全世界120多個國家。鮮乳制品、飲用水、嬰兒營養(yǎng)和醫(yī)療營養(yǎng)作為達能的四大主要產(chǎn)品，在全球市場銷量排名均名列前茅。達能集團自80年代末，將其投資眼光著力于中國市場，自此，中國成為達能集團發(fā)展策略中極為重要的市場。隨著達能在中國投資設(shè)廠，并廣泛開展其生產(chǎn)和業(yè)務(wù)，目前達能集團在中國的業(yè)務(wù)主要包括酸奶、飲料、嬰兒食品及醫(yī)療營養(yǎng)等，其從事相關(guān)產(chǎn)品的生產(chǎn)，其產(chǎn)品除本銷外，還出口到世界各國。中國，作為目前亞太地區(qū)商業(yè)活動的中心，近年來隨著中國經(jīng)濟的飛速發(fā)展，中國市場業(yè)務(wù)迅速膨脹，銷售額不斷迅速增長，因此，達能于2006年4月將亞太地區(qū)總部遷至上海，建立達能亞太（上海）管理有限公司，希望通過建立更貼近中國的管理機構(gòu)，進一步加大對中國市場的發(fā)展。達能亞太（上海）管理有限公司，作為達能集團的區(qū)域管理中心，主要由區(qū)域功能部門，如財務(wù)、人力資源、采購和市場等部門組成，并主要承擔核心管理和領(lǐng)導的職能。在達能，我們相信，創(chuàng)建包容性和多元化的團隊是我們未來的核心之一。所有符合條件的申請人都將得到平等的對待，我們不以應(yīng)聘人員的年齡、種族、民族、膚色、宗教信仰、國籍、性別、性取向、退伍軍人身份、遺傳信息或殘疾狀況等作為是否招聘的依據(jù)。加入達能亞太（上海）管理有限公司，更多機會與挑戰(zhàn)！The Danone Group, headquartered in Paris France, employs nearly 75,000 people worldwide in more than 120 countries. With outstanding brands in Fresh Dairy, Waters, Baby Nutrition and Medical Nutrition as well as being the world market leader in fresh dairy products, Danone is one of the fastest moving consumer goods company in the world.Danone has invested in China since 1980s and has in the last 20 years become the growth focus and strategic development country of the Group. Today, Danone is operational in its 4 main products line in China, and has obtained market leading positions in each of the categories.With the rapid growth in China market, the Danone Group has recently relocated its regional headquarter to Shanghai. This brings proximity of the Group’s strategic development and much enthusiasm to our China operations.As the regional headquarter for Asia-Pacific, Danone Asia-Pacific Management Co., Ltd., has many key, challenging opportunities in functions such as Finance, HR, Purchasing and Marketing.At Danone, we believe that creating inclusive and diverse teams is at the heart of our future. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, national origin, gender, gender identity, veteran status, genetic characteristic, or disability status.Join Danone today to
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