RA Intelligence Manager応募 Job ID R0006463 Location Shanghai, Shanghai Municipality, China;
1. Collect and analyze the latest policies, provide professional interpretation timely
2. Establish and maintain strong, effective working relationships with HA professionals, be able to predict the trend of national policy, and assist Takeda in formulating strategic directions from RA insights
3. Combine with Takeda pipeline to work out the specific strategic plan and provide the professional inputs
4. Industry analysis/monitor and influence, including but not limited to, competitors, industry events influence from Takeda etc.
Monitoring the requirements of HA, including but not limited to, regulation/guideline update, feedback from industry, etc. and generate analysis reports periodically to distribute cross-functionally. Collect and analyze regulatory information, such as, review and approval timeline of CFDA/CDE, priority review and on-site inspection lists, competitors including GQCE and develop evaluation report in a regular manner. Interpret regulations timely after release, conduct impact analysis and support strategy developing accordingly. Organize discussion for comments collection of draft regulations from RDPAC , and send feedback as requested. Effectively participate in associations (e.g., PDPAC, PhRMA), to establish and maintain strong, effective working relationships with HA professionals. Provide qualified, regulatory advice to the team, to make sure the regulatory activities are under the latest requirements of HA. Provide training sessions of latest regulations within Takeda cross-functional team. Prepare meeting materials and documents according to department needs. Others assigned by line manager.
GRA,TJT-P, Marketing, Access Excellence, TDC, etc.
RDPAC, PhRMA, CFDA, CDE, NIFDC, etc.
Level of Education
Bachelor degree or above, medicine or pharmacy related major
Working Experience in Relevant Field
>=5 years of related work experience;
Professional Knowledge and Skills
Be familiar with the laws and regulations on drug administration and registration management.
Excellent communication skills, both verbal and written. Proficiency in English is a must.
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation and database applications.