應(yīng)屆畢業(yè)生
本科
2025-07-22 18:30:18
934人關(guān)注
職位描述
該職位還未進(jìn)行加V認(rèn)證，請仔細(xì)了解后再進(jìn)行投遞！
Collaborate and Communicate with China PBG President on the ways to help the country meet annual objectives of different BUs and ensure regulatory supports to the marketing and sales effort through:
● Assist line manager to complete registration projects for new products, variations of marketed products and license renewals within the set timeframe and conduct in compliance with local regulatory agency requirements as well as relevant Pfizer SOPs.
● Closely follow up submission, QC testing, evaluation and approval in CNDA, CDE and official labs.
● Keep communication with HQ and other internal functional teams.
● Keep alert on regulatory intelligence.
● Develop and improve good working relationship with HA and KOLs.
● Report to line management regularly.
● Maintain and update the Local Product Document (labeling) and Artworks in accordance with relevant regulations and Pfizer SOPs.
● Partner with the global regulatory and clinical development team in china PBG BUs for new products development strategy and inline products strategy.
● Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.
● Partner with PGS for supply strategy to avoid supply issue due to site changes.
● Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices.
● Ensuring Regulatory Compliance.
● Ensure timely communicate the requirement of CHP and other China regulations to PGS QO and GCMC to facilitate the implement of CHP and other regulations in PGS sites.
● Ensure local process in place for the timely submission of all the quality and safety relevant variations including labeling safety update and specification/manufacture process change.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
#LI-PFE
● Assist line manager to complete registration projects for new products, variations of marketed products and license renewals within the set timeframe and conduct in compliance with local regulatory agency requirements as well as relevant Pfizer SOPs.
● Closely follow up submission, QC testing, evaluation and approval in CNDA, CDE and official labs.
● Keep communication with HQ and other internal functional teams.
● Keep alert on regulatory intelligence.
● Develop and improve good working relationship with HA and KOLs.
● Report to line management regularly.
● Maintain and update the Local Product Document (labeling) and Artworks in accordance with relevant regulations and Pfizer SOPs.
● Partner with the global regulatory and clinical development team in china PBG BUs for new products development strategy and inline products strategy.
● Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.
● Partner with PGS for supply strategy to avoid supply issue due to site changes.
● Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices.
● Ensuring Regulatory Compliance.
● Ensure timely communicate the requirement of CHP and other China regulations to PGS QO and GCMC to facilitate the implement of CHP and other regulations in PGS sites.
● Ensure local process in place for the timely submission of all the quality and safety relevant variations including labeling safety update and specification/manufacture process change.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
#LI-PFE
注：聯(lián)系我時，請說是在蘿崗人才網(wǎng)上看到的。
工作地點
地址：北京東城區(qū)五礦廣場
求職提示：用人單位發(fā)布虛假招聘信息，或以任何名義向求職者收取財物（如體檢費(fèi)、置裝費(fèi)、押金、服裝費(fèi)、培訓(xùn)費(fèi)、身份證、畢業(yè)證等），均涉嫌違法，請求職者務(wù)必提高警惕。
職位發(fā)布者
輝瑞HR..HR
輝瑞制藥有限公司
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制藥·生物工程
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1000人以上
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外商獨資·外企辦事處
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碑林區(qū)和平路116號金鼎大廈303
