職位描述
Location: Beijing
Role Purpose:
To assist and support the Manager in preparing and submitting the documentation for new products registration, renewal and variations of existing regulatory approvals for vaccines imports.
Key Accountabilities / Responsibilities:
· Establish, maintain and develop good relationships with the CFDA, to facilitate and expedite regulatory approvals and as required with other regulatory authorities (CDE, NIFDC).
· Advise and resolve specific issues to achieve agreed milestones and ensure that submitted documentation meets CFDA and GSK requirements.
· Ensure that GSK Bio. Regulatory Affairs is kept fully informed on the current regulatory status of all assigned products.
· Ensure that Import vaccines labeling and PI is consistent with CFDA guidelines and requirements.
· Order, translate, compile and prepare registration dossiers into an effective, professional document for submission to CDE.
· Draft for approval by the Manager, local prescribing information (PI) that it is both competitive and fully conforms with CFDA and GSK requirements.
· Collect and communicate to the Manager any information that relates to the registration and administration of medicines in China; including new legislation, changes to the regulatory requirements, guidelines etc.
· As required co-ordinate activities with GSK Bio.
· Assist the Manager in supporting and providing a service to other functions and departments (e.g. Clinical and Marketing).
Qualifications / Requirements:
(Education / Experience / Competencies)
Qualification:
Minimum 1-2 years working experience in regulatory affairs related field.
Good verbal and written communication skills.
Expert knowledge of regulatory policies and registration processes in China.
Excellent inter-personal skills.
A strong capability in problem solving.
Extensive and close contacts with authority.
Knowledge:
Proven ability to communicate (written/oral) in English.
Good verbal and written communication skills.
Proven competency with the following computer software: Word, Powerpoint, Excel.
A comprehensive understanding of the Chinese registration requirements and regulations.
Good understanding of the structure, functions and operating procedures of the CFDA, CDE and NIFDC.
Complexity:
In an environment where regulatory issues are often uncertain, analyze complex problems, assess alternatives and propose solutions to the Manager.
Persuade the regulatory authorities to accept GSK requirements in the absence of definitive regulations.
Independently manage and resolve issues arising from laboratory testing.
Identify and implement solutions regarding methodologies, reagents and instrumentation.
Preparation and drafting of regulatory dossiers.
Key Job Dimensions (financial scope, headcount etc):
Cross functional co-operation with strong ownership and cross boundary working mindset.
