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月薪范圍：登錄可見

招聘人數：若干

年齡要求：不限

所屬職能：生產/科研/質管類

工作地點：北京

學歷要求：不限

語言要求：不限

所屬崗位：注冊專員/經理

工作年限：不限

專業要求：不限

五險一金帶薪年假年底雙薪定期體檢節日福利

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.

企業簡介

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

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Senior Associate, Regulatory Submissions

職位描述

企業簡介

職位發布企業

科文斯醫藥研發（北京）有限公司上海分公司

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