HireDiversity

Beijing, CN

Regulatory Affairs Associate Director-Beijing-Guangzhou Bioseal Plant-000008CY

Description

The employee of this position will sign labor contract with Guangzhou Bioseal Biotech Co., Ltd

General Summary
The Regulatory Affairs Manager/Assoc Director, Bioseal China will provide regulatory capabilities to the Bioseal business within China specifically focused on clinical strategy related to indication expansion for the Bioseal pipeline products. The Regulatory Affairs Manager/Assoc Director will be responsible for ensuring execution of optimal regulatory strategies, and supporting key interfaces with SFDA for combination biologic/device. In addition, this position will be responsible for submitting pre-submission meeting packages, clinical trial applications, and marketing application submissions supporting new indications per the strategic business plan for Bioseal.

Principal Duties and Responsibilities
• Accountable for regulatory submissions for Bioseal products, focused on clinical/new indication related activities.
• Ensures successful execution of regulatory strategy including regulatory agency interface, submissions and reports for Bioseal projects, under the direction of the RA department head.
General Summary
The Regulatory Affairs Manager/Assoc Director, Bioseal China will provide regulatory capabilities to the Bioseal business within China specifically focused on clinical strategy related to indication expansion for the Bioseal pipeline products. The RA Mgr/Assoc Dir will be responsible for ensuring execution of optimal regulatory strategies, and supporting key interfaces with SFDA for combination biologic/device. In addition, this position will be responsible for submitting pre-submission meeting packages, clinical trial applications, and marketing application submissions supporting new indications per the strategic business plan for Bioseal.

Qualifications


•• Minimum 3-5 years regulatory experience in the regulated industry required; preferably in biopharmaceutical or pharmaceutical industry.
• Prior experience with SFDA is preferred.
• Strong technical writing skills are required.
• Fluency in Chinese and proficiency in English language required
• China-based position (Beijing)
• Travel 10%.

Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Regulatory Affairs