Senior Manager, Regulatory Project Management and Excellence, GRA China

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Job Description

Objective / Purpose:

• Provide insights into initiative, strategy and activity to facilitate effective and excellent project operations.

• Keep close contact with local and global stakeholders and cooperate with GRA operation and compliance.

• Establish and ensure effective working models with internal stakeholders (global, regional, TDC, local commercial, etc.) and build the culture of partnership.

• Project specific input for execution excellence.

Accountabilities:     

• Building up RA operations in-house team capability development according to external and internal.
• Nurture innovation and solving problems creatively, commitment to excellence.

• Analyze industrial practice and find out the areas which need to be improved and provide solutions.

• Support the establishment and assessment of regulatory affairs capability and development scheme.

• Streamline the working model for regulatory affairs team through the comprehensive understanding of the model of collaboration functions.

• Organize/lead discussion on high frequency questions/issues and generate action plans.

• Provide insights into the RA function daily work and work out the improvement plan if needed.

• Assigned tasks including publishing and others.                                                                                                                                                                                

R&D Qualifications & Skills

·       Level of Education: Bachelor’s degree or above; Clinical medicine, life science (e.g. Chemistry, Pharmaceutics, Biochemistry, Biotechnology, Biology) or equivalent.

·       Working Experience in Relevant Field: Over 7 years’ experience in pharmaceutical industry or consultant firm over watching pharmaceutical industry, RA knowledge is preferred. Strategic thinking and big picture orientation.

·       Professional Knowledge and Skills: Familiar with the pharmaceutical products related policy, law and regulations; Have sense of pharmaceutical industry competitive landscape; Excellent communication skills in Chinese and English, both verbal and written; Expert in handling MS office (word, excel, PowerPoint etc.)

·       Desired education qualifications and equivalencies (e.g., PhD degree in a scientific discipline with 6+ years’ experience, or MS with 10+ years’ experience, or BS with 12+ years’ experience

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