Job description

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.

Requirements

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

Required Languages

English