Quality and Regulatory Affairs Specialist
Quality and Regulatory Affairs Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Corporate Quality and Regulatory Affairs Specialist China
Location Los Angeles CA
Start Date: Mar 2025 to End Date: Sep 2025
Schedule: 8:00 AM to 4:30 PM
Summary:
Responsible for coordinating the activities in the areas of Regulatory and Quality of Grifols 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 clients 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 (Client name) China manage communications with distributor and support communications with Chinese Health authorities conducted by the Technical Direction of client in 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:
Bachelors degree in life science pharmacy pharmaceutical science or related fields Fluent in English and Chinese (in reading writing and speaking) Minimum of 5years 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
Employment Type
Full Time
