Senior Manager, Regulatory Project Management and Excellence，GRA China
Description
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Job Description
Job Description
Job Title:
RA Senior Manager of Regulatory Project Management and Excellence
BU/Organization:
R&D
Department/
Function:
GRA
Location and Flex Work Arrangement:
Beijing or Shanghai; Hybrid
Job Code/
Job Profile:
not required for contractor
CHN R&D - Senior Manager, Regulatory Project Management and Excellence
Supervisor:
Zhizhong Duan
RA Operations Head
Compensation Grade Profile:
not required for contractor
CHN - TDC - Regional Grade F - Premium
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:
1. 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.
Education & Competencies (Technical and Behavioral):
· 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