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Role Purpose 職位目標：

To provide strategic and technical regulatory CMC support to line manager for the purpose of commencing and maximizing business by facilitating the CMC submission and approval in a timely and high-quality manner.

Key Accountabilities/Responsibilities 主要工作職責：

With guidance from the line manager, work closely with LOC and central team to provide CMC regulatory support to address CMC issues/challenges in products China filings, including IND, NDA, post-approval and renewals. Which include:

在直線經(jīng)理的指導(dǎo)下，與本地運營中心（LOC）及總部團隊緊密合作，針對在中國進行的產(chǎn)品申報（包括新藥臨床試驗申請（IND）、新藥申請（NDA）、批準后事項及續(xù)期等）中出現(xiàn)的 CMC 問題 / 挑戰(zhàn)提供 CMC 法規(guī)支持。

1. In charge of all RA CMC relevant activities of new products (IND/CTA/NDA) and established products (Variation and renewal), including CMC strategy making and implementation, CMC document preparation, CMC technical review follow up, HA communication for CMC topics, QC testing, GMP on-site inspection, ChP, etc.

負責新產(chǎn)品（IND/CTA/NDA）及已上市產(chǎn)品（變更及續(xù)期）的所有注冊事務(wù)（RA）CMC 相關(guān)活動，包括 CMC 策略的制定與實施、CMC 文件的準備、CMC 技術(shù)審核的跟進、就 CMC 相關(guān)議題與藥監(jiān)局（HA）的溝通、質(zhì)量控制（QC）檢測、藥品生產(chǎn)質(zhì)量管理規(guī)范（GMP）現(xiàn)場檢查、中國藥典（ChP）等相關(guān)事宜。

2. Provide technical regulatory CMC input and support to line manager to contribute on implementing regulatory CMC strategy and plan to deliver the highest value to business.

為直線經(jīng)理提供技術(shù)法規(guī)層面的 CMC 意見和支持，助力實施法規(guī) CMC 策略和計劃，從而為業(yè)務(wù)創(chuàng)造最大價值

3. Compile high quality CMC filing document complying with external and internal requirement to provide right and clear drug profile and data to CFDA to achieve targeted labeling and drug features to be approved.

編制符合內(nèi)外部要求的高質(zhì)量 CMC 申報文件，向國家食品藥品監(jiān)督管理總局（CFDA）提供準確清晰的藥品概況及數(shù)據(jù)，以實現(xiàn)目標標簽及藥品特性獲批。

4. Coordinate registration testing activities, including sample/reagents/reference
standards/Cell lines/consumable preparation/importation/customs clearance/arrangement for delivery to HA lab, contract/registration testing submission and achieve, follow up contracting/registration testing progress, address queries/challenges during registration testing, etc.

協(xié)調(diào)注冊檢測活動，包括樣品 / 試劑 / 參考標準品 / 細胞系 / 耗材的準備 / 進口 / 報關(guān) / 安排運送至藥監(jiān)局實驗室、合同 / 注冊檢測申報及完成、跟進合同 / 注冊檢測進度、解決注冊檢測過程中的疑問 / 挑戰(zhàn)等。

5. In support of the line manager, to coordinate CMC query response activities including query responses strategy and timeline development, response dossier preparation, facilitate communication with CDE/NIFDC/CFDA/CPC, etc via professional communication to establish and maintain a good relationship with key CMC regulatory authority in daily work.

在支持直線經(jīng)理的工作中，協(xié)調(diào) CMC 答疑活動，包括制定答疑策略及時間表、準備答疑文件、通過專業(yè)溝通促進與國家藥品審評中心（CDE）/ 中國食品藥品檢定研究院（NIFDC）/ 國家食品藥品監(jiān)督管理總局（CFDA）/ 中國專利局（CPC）等機構(gòu)的溝通，以便在日常工作中與主要的 CMC 監(jiān)管機構(gòu)建立并維持良好關(guān)系。

6. Engage with internal and external CMC stakeholders to follow up every CMC milestone closely to ensure issue identified, escalated, resolved timely and target CMC filing and approval timeline plan is achieved.

與內(nèi)外部 CMC 相關(guān)方合作，密切跟進每個 CMC 里程碑事件，確保及時發(fā)現(xiàn)、上報并解決問題，實現(xiàn) CMC 申報及獲批的目標時間表計劃。

7. Make sure line manager fully informed CMC projects registration status in daily work.

在日常工作中確保直線經(jīng)理充分了解 CMC 項目的注冊狀態(tài)。

8. Provide timely and high-quality CMC regulatory support and input to internal key stakeholders such as medical, commercial and GMS site as needed.

根據(jù)需要，為醫(yī)療、商業(yè)及全球生產(chǎn)供應(yīng)（GMS）基地等內(nèi)部關(guān)鍵利益相關(guān)方提供及時、高質(zhì)量的 CMC 法規(guī)支持和意見。

9. Ensure timely and flawless implementation of company SOP and compliance requirement in daily work.

在日常工作中確保公司標準操作程序（SOP）及合規(guī)要求得到及時、無差錯的執(zhí)行

Qualifications/Requirements:
(Education / Experience / Competencies)

申請資格 / 職位要求：(教育背景 / 工作經(jīng)驗 / 知識與技能)

1. A minimum of bachelor’s degree in life science (pharmacy, chemistry, biology or related background)

生命科學（藥學、化學、生物學或相關(guān)專業(yè)背景）專業(yè)本科及以上學歷。

2. Minimum 3 years’ experience in regulatory affairs/CMC field and experience in MNC preferred

至少 3 年在法規(guī)事務(wù) / CMC 領(lǐng)域的工作經(jīng)驗，有跨國公司工作經(jīng)驗者優(yōu)先。

3. Proven ability to communicate (written/oral) with various functions and with authority.

具備與各職能部門及相關(guān)機構(gòu)進行（書面 / 口頭）溝通的能力。

4. Fluency in English

英語流利。

5. Ability of cross functional co-operation. Strong ownership and cross boundary working mindset

具備跨部門合作能力。有強烈的責任心和跨界工作思維。

6. A strong capability in problem solving

具備較強的問題解決能力。

7. Strong ability of lobby, influence and negotiation

具備較強的游說、影響及談判能力。