HireDiversity

Guangzhou (Canton), CN

Regulatory Affairs Specialist-Guangzhou Bioseal Plant-000008D4

Description

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

General Summary
The Regulatory Affairs Specialist, Bioseal China will provide technical regulatory capabilities to the Bioseal business within China specifically focused on CMC regulatory affairs activities. The RA Specialist will be responsible for ensuring execution of optimal regulatory strategies, and supporting key interfaces with Asia Pacific regulatory agencies for combination biologic/device. In addition, other duties include regulatory support to Supply Chain, operations and Quality in process, materials and component changes. The RA Specialist will be responsible for maintaining the approvals/clearances through copy review, required reports and other regulatory submissions under the direction of the Regulatory Affairs Department Head.

Principal Duties and Responsibilities
• Accountable for regulatory submissions for Bioseal products, focused on CMC 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.
• Accountable for maintenance of Asia Pacific approvals/clearances through copy approval, relevant inspection support, and required agency reports and post-approval submissions.

Qualifications


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

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