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发帖数: 1322 | 1 Aleon Pharma International, Inc.
Aleon Pharma International Inc. is a company engaging in the development of
pharmaceutical and biotechnological products. Our mission is to become a
leader in the development of innovative, safe, and efficacious
pharmaceutical and biotechnological products that ultimately improve human
health. Due to business growth, we currently have the following career
opportunity opening in Parsippany, New Jersey.
Project Manager- Drug Regulatory Affairs
ESSENTIAL DUTIES AND RESPONSIBILITIES
The primary duties and responsibilities of this position include the
following. Other duties may be assigned.
• Prepare IND and amendment submissions to the FDA.
• Maintain professional communication with FDA.
• Study FDA/ICH/EMA regulation and guidance and prepare regulatory due
-diligence analysis.
• Learn to develop strategy for new drug/biologics development.
• Manage project planning, operation and reporting of assigned
projects.
• Represent company on project meetings with clients/CROs.
• Review technical documents to assure compliance with FDA
requirements and industry standards.
• Work in a cooperative manner with coworkers and customers.
• Uphold Company policies, the Business Ethics and Conduct Code.
EDUCATION AND EXPERIENCE
• Advanced degree (Ph.D. preferred) in Medical/Pharmaceutical/
Biological Sciences/Chemistry or related fields from an accredited
university or college.
• Experience/training in regulatory affairs preferred. We are willing
to train exceptional candidates who can demonstrate quality and potential.
QUALIFICATIONS
• Excellent interpersonal written and oral communication skills.
Proficient in English and Chinese.
• Strong desire to learn. Ability to thrive in a dynamic and fast-
paced environment.
• Exceptional attention to detail and excellent organizational skills.
• Be creative.
This is an excellent opportunity for the right candidate. We provide
excellent professional training and learning opportunities. We offer
friendly, supportive working environment and excellent benefits. Candidates
should send resume with confidence to [email protected] |
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