P***B
发帖数: 1 | 1 有兴趣的朋友请联系：
黄凯 （Kerwin） ，国内电话：028-86703680， 1355832040， 美国电话：2156352297
邮箱：[email protected]
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--------------------------------职位一 -----------------------------------
【Job Description – Associate Director, Regulatory Affairs】
====Reporting to Executive Director of Regulatory Affairs, the incumbent
will be responsible for outlining the regulatory strategy, coordinate
activities related to regulatory interactions, such as global regulatory
filing, meetings, etc.
====Responsibilities:
Actively contribute to the development and implementation of global
regulatory strategies for assigned projects ? Serve as the primary point of
contact with health authorities, especially FDA and EMA ? Act as a
regulatory liaison to interact with the external partners, and internal-
functional departments; participate in or lead project teams ? Be
responsible for managing the preparation, compilation, and submission of
regulatory applications, such as INDs / CTAs, BLAs / MAAs, and their
supplemental filings ? Collaborate with CRO’s and cross-functional partners
throughout the drug development process to ensure compliance with
regulatory requirements ? Stay abreast of global competitive landscape,
regulatory environment, regulations and guidance ? May supervise one or more
junior staff ? Participate in Business Development efforts, as assigned
====We are looking for someone who:
Is a self-starter, and able to work well independently ? Willing to accept
challenges and be flexible to take upon broad responsibilities in a fast-
growing, small company environment ? Is a team player, works well in a team
environment both as a leader and a key contributor
====Requirements:
Minimum Bachelor’s degree in a scientific or related disciplines, 7+
years of pharmaceutical industrial experience, minimum 5 years in Regulatory
Affairs. Global experience desirable ? Working knowledge of global
regulations and guidances as they relate to the global regulatory strategy ?
Working experience of eCTD submission ? Excellent organizational, oral and
written communication skills. Fluent in Chinese is prefered but not required.
-------------------------------------职位二 -------------------------------
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【Job Description – Manager, Regulatory Affairs】
===Working closely with Associate Director of Regulatory Affairs, the
incumbent will be responsible for outlining the regulatory strategy,
coordinating activities related to regulatory interactions, such as global
regulatory filing, meetings, etc.
====Responsibilities:
With some guidance, contribute to the development and implementation of
global regulatory strategies for assigned projects ? Act as a regulatory
liaison to interact with the external partners, and internal-functional
departments; participate in or lead project teams ? Be responsible for
managing the preparation, compilation, and submission of regulatory
applications, such as meeting packages, INDs / CTAs, BLAs / MAAs, and their
supplemental filings ? Collaborate with CRO’s and cross-functional partners
throughout the drug development process to ensure compliance with
regulatory requirements ? Stay abreast of global competitive landscape,
regulatory environment, regulations and guidance
====We are looking for someone who:
Is a self-starter, and able to work well independently ? Willing to accept
challenges and be flexible to take upon broad responsibilities in a fast-
growing, small company environment ? Is a team player, works well in a team
environment either as a leader or a key contributor
====Requirements:
Minimum Bachelor’s degree in a scientific or related disciplines, 5+
years of pharmaceutical industrial experience, minimum 3 years in Regulatory
Affairs. ? Working knowledge of current regulations and guidances ?
Excellent organizational, oral and written communication skills. Fluent in
Chinese preferred, but not required |
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