Senior Manager, Regulatory Project Management and Excellence, GRA China
Beijing, Beijing Municipality Job ID R0193156 Category Regulatory Affairs Subcategory Research & Development Business Unit Research & Development Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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
