厦门招聘

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:

• A minimum of bachelor degree in Biological or Pharmacy.

• 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.

• Knowledge of the relevant technical manufacturing operations including operations management, GMP and QA/QC.

• Possesses an established record of preparing and achieving product registrations.

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.

• To manage and comprehend the large amounts of technical data/information required for regulatory submissions and expert panel reviews.

  Independent Thinking:

• 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):

• Provide to senior Management details of the regulatory status of competitors.

• Consult with and advise Marketing on product labeling.

Cross functional co-operation with strong ownership and cross boundary working mindset.

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