Job Summary
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Company
Guangzhou Link Health Pharma Co.,Ltd.
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Location
Guangzhou Guangdong, China
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Job Type
Full Time
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Salary Range
15,000-20,000 RMB
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Number to Recruit
1
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Job Reference Code
J2000293
Regulatory Affairs Manager
Link Health is a biopharmaceutical company developing innovative medicine for unmet medical needs. It has a drug development pipeline of 5 clinical stage assets and 1 under NDA reviewing in China. Headquartered in China, Link Health has an European office in the Netherlands to further strengthen the collaborations with global biopharmaceutical .
Responsibilities:
l Compile registration dossier and ensure timely regulatory submission of import drug application or local manufacturing application.
l Keep tracking the project registration process and resolve any issue timely to ensure earliest possible registration.
l Communicate with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
l Continuously monitor the new regulations and policies of healthcare and pharmaceutical products, and ensure the potential impact to projects or company business have been thoroughly evaluated and well communicated.
Qualifications:
l Medical/pharmacy/life sciences background, B.S. or above
l Over 2 years regulatory experience in a globe leading pharmaceutical company or CROs
l Familiar with ICH-M4 and ICH-M8 guidelines，has CTD documents writing experience.
l Excellent communication skills and convincing skills in both Chinese and English
l Good team player
l Open attitude, Willing to meet challenges
