i*****c
发帖数: 1322 | 1 【 以下文字转载自 Chemistry 讨论区 】
发信人: iminusc (布衣王二), 信区: Chemistry
标 题: CMC regulatory affairs manager
发信站: BBS 未名空间站 (Mon Sep 19 20:41:37 2016, 美东)
新泽西一个咨询公司需要一位化学背景的CMC RA manager. 最好是化学博士，不需要解
决身份的。有兴趣请发简历到：[email protected]/* */！ | i*****c
发帖数: 1322 | 2 Due to business expansion, we currently have the following career
opportunity opening in Parsippany, New Jersey.
Project Manager- CMC Drug Regulatory Affairs
ESSENTIAL DUTIES AND RESPONSIBILITIES
The primary duties and responsibilities of this position include the
following. Other duties may be assigned.
• Manage project planning, operation and reporting of assigned
projects.
• Represent company on project meetings with clients.
• Review Chemistry, Manufacturing and Controls (CMC ) documents to
assure compliance with FDA requirements and industry standards.
• Prepare IND, ANDA and amendment submissions to the FDA.
• Study FDA regulation and guidance and prepare regulatory analysis
report.
• Work in a cooperative manner with coworkers, customers and the
public.
• Uphold Company policies, the Business Ethics and Conduct Code.
EDUCATION AND EXPERIENCE
• Ph.D. in Chemistry (medicinal/pharmaceutical chemistry, organic
chemistry, analytical chemistry or related fields) from an accredited
university or college.
• Experience/training in CMC drug regulatory affairs preferred. We
are willing to train exceptional candidate(s) who can demonstrate quality
and potential.
• Experience or understanding of drug development process.
• Training in computer/good computer skills desired.
QUALIFICATIONS
• Excellent interpersonal written and oral communication skills.
Proficient in English and Chinese (preferred).
• Strong desire to learn. Ability to thrive in a dynamic and fast-
paced environment.
• Exceptional attention to detail and excellent organizational
skills.
This is an excellent opportunity for the right candidate. We provide
excellent professional training and learning opportunities. We offer
friendly and supportive working environment. Candidates should send resume
with confidence to [email protected]/* */ |
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