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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Beijing, China

Job Description:

Manages submission of new product applications to the regulatory agencies. Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies. Provides guidance to project team members regarding regulatory compliance issues. Oversees the preparation and maintenance of regulatory submissions and files. Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products and other products. Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters. Consults with management personal to establish strategies and prepare appropriate regulatory filings for the regulatory activities. In general, has responsibility for projects of medium and large scope, such as accountability for regional/global/multi-functional projects.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaborating, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking