Regulatory Affairs Manager (注册事务经理)

Entity: Baxter (China) Investment Co., Ltd
Division:Regulatory Affairs
Report to:Asso. Regulatory Affairs Director
Subordinate********
Location:Beijing


Job Description

The RA Manager Position will report to the Associate RA ********base******** Beijing an******** regulatory support on import nutritionor anesthesia products』 maintenance an******** to China markets.

Responsibilitie********

Being A RA Manager, the professional in this position will fulfillregulatory responsibilities including but not limite******** thefollowing:

1.Establish a thorough submission plan with strategic thinking for eachassignment within the timeline agree******** stakeholders;

2.Obtain timely approval for new drugs an******** other necessaryapprovals for the existing products maintenance.

3.Ensure regulatory/legal compliance of regulatory activities.

4.Liaising with the relevant governmental bodies an******** authorities

5.SFDA, CDE, NIFDC

Qualification********

1.Bachelor degree or above, major in pharmaceutical or relate********;

2.At least 7 years of experience in pharmaceutical industry;

3.Excellent knowledge an******** in Drug registration an********technical guidelines.

4.Goo******** with CFDA an******** relevant affiliates.

5.Goo******** sk******** creative th******** with teamwork spirit;Result an******** oriente******** able to work under pressure to meettight timelines

6.Goo******** an******** English + Mandarin

Goo******** skill.