Key Responsibilities: - Compile registration dossier and ensure timely regulatory submission of import drug application or local manufacturing application. - Keep tracking the project registration process and resolve any issue timely to ensure earliest possible registration. - Communicate with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing. - 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.
Qualification: - Medical/pharmacy/life sciences background, B.S. or above - Over 2 years regulatory experience in a globe leading pharmaceutical company or CROs - Familiar with ICH-M4 and ICH-M8 guidelines，has CTD documents writing experience. - Excellent communication skills and convincing skills in both Chinese and English - Good team player - Open attitude, Willing to meet challenges
Legal / Compliance
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