Overview
Regulatory Affairs Specialist Jobs in Los Angeles, California, USA at Belcan
This range is provided by Belcan. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$36.00/hr – $43.00/hr
Senior Technical Recruiter at Belcan | People Person
Job Title:
Corporate Quality and Regulatory Affairs Specialist (China)
Pay Rate: $36.06 – $43.27 /hr
Start Date:
Right Away
Benefits:
Medical / Health Benefits with multiple plan options
Flexible Spending Accounts
Dental and Vision
401k
On the job training / cross-training
Life Insurance, disability insurance, and voluntary life insurance for family members available
Accident and critical illness insurance optional
Scheduled performance reviews
Referral program
Job Description:
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.
Responsibilities:
Participate communications related to Quality and Regulatory Affairs between the Bioscience industrial group and company’s Chinese branch
Manage communications with distributor and support communications with Chinese Health authorities conducted by the Technical Direction of Chinese branch and his/her team
Provide direct and clear communication to management regarding the current status of quality and regulatory for China
Participate 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
Education and Experience:
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
Seniority level
Not Applicable
Employment type
Part-time
Job function
General Business
Industries
Pharmaceutical Manufacturing
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Title: Regulatory Affairs Specialist
Company: Belcan
Location: Los Angeles, California, USA
Category: Quality Assurance – QA/QC, Pharmaceutical
