Regulatory Affairs Specialist

职位 Regulatory Affairs Specialist
汇报对象 RA Manager
工作地点 Suzhou

Support the management by being responsible for the registration of new products for local market and renewal of existing certificates.

  • Executing the registration process in order to ensure timely renewal of existing certificates as well as approvals of new drug products in local marketing, manufacturing permits, import/export permits and amendments to products.
  • Prompt follow-up, provide necessary advice and coordinate with internal parties.
  • Develop and maintain established network with external parties, esp. testing center, SFDA and vendors to ensure ongoing cases completed on time.
  • Plan, timely update, forecast and monitor each ongoing case from a project management point of view.
  • Assist department head with spontaneous cases as well as providing necessary assistance to colleagues with relevant requirements from time to time.
  • Other tasks assigned by superior.
  • Bachelor degree or above, major in Chemistry or pharmaceutical major or other related majors.
  • At least 3 years' related experience in Pharmaceutical/Medical Device Registration.
  • Fluent English in oral &written.
  • Mature with good interpersonal Communication skills.
  • Result Oriented and eager to take challenges.