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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.