Regulatory Affairs Manager

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