Corporate Quality and Regulatory Affairs Specialist – China
ICONMA, LLC
Our Client, a Pharmaceutical company, is looking for a Corporate Quality and Regulatory Affairs Specialist – China for their Los Angeles, CA location. Responsibilities:
+ Responsible for coordinating the activities in the areas of Regulatory and Quality of Client 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 Client’ facilities and operations by Chinese Authorities /distributors/customers.
+ Participate communications related to Quality and Regulatory Affairs between the Bioscience industrial group and Client China, manage communications with Client distributor and support communications with Chinese Health authorities conducted by the Technical Direction of Client 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:
+ Requirements: Bachelor's degree in life science, pharmacy, pharmaceutical science or related fields Fluent in English and Chinese (in reading, writing, and speaking) Minimum of 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
+ Requirements: Degree / Cert
Why Should You Apply?
+ Health Benefits
+ Referral Program
+ Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
Confirm your E-mail: Send Email
All Jobs from ICONMA, LLC