Senior Manager, Regulatory Project Management and Excellence, GRA China

By 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 Locations Beijing, China Worker Type Employee Worker Sub-Type Regular Time Type Full time