Position: Specialist of Regulatory Affairs

Location: Beijing/Shanghai, China

Report to: Manager of Regulatory Affairs

Key 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.

Qualification:

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 Be familiar with regulations and guidelines in CFDA, FDA and EU

l Excellent communication skills and convincing skills in both Chinese and English

l Good team player

l Open attitude, Willing to meet challenges

Qualified candidates are welcomed to send your CV to hr@wuxipra.com .