Corporate Quality & Regulatory Affairs Specialist (China)

Our major pharmaceutical client in Los Angeles is seeking a Corporate Quality and Regulatory Affairs Specialist to ensure compliance and regulation of their Chinese group.

Location - Los Angeles, CA

Length 6 month Plus

Hybrid Role 3 days a week in office

Job Description

Summary: Responsible for coordinating the activities in the areas of Regulatory and Quality of Biopharma business to ensure Chinese regulations are met. The principal functional responsibilities include handling and coordinating the investigation of Customer Complaints from China, assisting product and process submissions to Chinese Regulatory Authorities, managing quality or RA projects that involves multiple departments/companies, and supporting cGMP inspections of facilities and operations by Chinese Authorities /distributors/customers.

Primary responsibilities for role: Participate communications related to Quality and Regulatory Affairs between the Bioscience industrial group and China, manage communications with distributor and support communications with Chinese Health authorities conducted by the Technical Direction of China and his/her team. Provides direct and clear communication to management regarding the current status of quality and regulatory for China. Participates in regulatory inspections/audits from China as facilitator, translator during the inspection or in the written responses, if applicable. Communicates with cross functional departments and support groups to improve departmental performance and efficiency Host meetings and generate meeting minutes

Requirements:

Bachelor's degree in life science, pharmacy, pharmaceutical science or related fields

Fluent in English and Chinese (in reading, writing, and speaking)

Minimum 5-years GXP experience in biotech/pharmaceutical industry

Familiar with FDA regulations on parenteral drugs

Experience in plasma fractionation industry is a plus

Strong skills in project management