Amgen Regulatory Affairs Sr Mgr in Beijing, China
Monitor regulatory environmentincluding policy, regulations, guidelines NMPA andCDE’sreform planning. to assess the impact changes andcommunicate with internalkey stakeholder in a timely manner. To give the perspectives on policy and regulation standing in the front of development strategy.
Organize internal react to the new policy, regulation and guideline to give comments
To be activeplayersinRDPAC.Welldelivercompany’s position toRDPACand impact theauthoritythroughRDPAC.
To build up the connection with industry and become the intelligence center.
To develop China local working process or SOP according to global SOP.
To be responsible for RA compliance and RA internal audit; lead RA audit preparationandensure compliance.