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Senior Associate, Regulatory Submissions

月薪范圍：登錄可見

招聘人數(shù)：若干

年齡要求：不限

所屬職能：生產(chǎn)/科研/質(zhì)管類

工作地點：北京

學(xué)歷要求：不限

語言要求：不限

所屬崗位：注冊專員/經(jīng)理

工作年限：不限

專業(yè)要求：不限

五險一金帶薪年假年底雙薪定期體檢節(jié)日福利

職位描述

*Responsibilities/Duties

?Prepare routine submissions filed to Regulatory Authorities (e.g. INDs/CTAs, HGRAC, Import permits, export permits and NDAs) in China.
?Will take ownership for specific pieces of work and may be the Regulatory Affairs lead for projects.
?Review/summarize/compile scientific/research documents in preparation for submission to Regulatory Authorities.
?Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.
?Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.
?Responsible for maintaining awareness of regulatory legislation, guidance and practice pertaining to assigned product/project areas.
?Assure compliance with regulatory requirements in relation to assigned projects.
?Participate in project development and regulatory strategy planning sessions. Will participate independently in client meetings and will proactively liaise with clients on regulatory submission issues.
?Work on special regulatory projects as assigned.

*Education/Qualifications

Bachelor’s Degree in Life Sciences or equivalent.

*Experience

Minimum Required:

？Excellent communication skills, organization and planning skills and attention to detail.

？Minimum of 3 years experience in the pharmaceutical industry preferably in regulatory affairs or drug development.

企業(yè)簡介

科文斯，全球性的合同研究組織（CRO）Covance Inc.是全球服務(wù)最全面的藥物研發(fā)公司。
我們致力于推動醫(yī)療保健事業(yè)發(fā)展并實現(xiàn)Solutions Made Real?，通過向制藥公司和生物科技公司提供高質(zhì)量的非臨床、臨床前試驗、臨床和商業(yè)化服務(wù)，幫助減少藥物研發(fā)的時間和成本。憑借豐富的經(jīng)驗與深厚知識，我們具備獨特的優(yōu)勢，能為客戶合作伙伴提供不僅僅局限于測試的獨到見解。
我們還向化學(xué)品、農(nóng)用化學(xué)品和食品行業(yè)提供實驗室測試服務(wù)，同時也是毒理學(xué)分析服務(wù)、中心實驗室服務(wù)、藥物篩選服務(wù)的市場領(lǐng)導(dǎo)者，以及III期臨床試驗管理服務(wù)的全球頂級提供商。
科文斯官網(wǎng)： https://www.covance.com/

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