Regulatory Affairs Specialist/Senior Specialist

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PRIMARY FUNCTION:

  • Regulatory Affairs

MAJOR RESPONSIBILITIES, AND DUTIES:

  • Support IND, CTA, NDA filing to China and US health authority ;
  • Liaise with project coordinators and under guidance of Head of RA in executing submission strategies and filing timeline, addressing queries from health authorities;
  • Support regulatory operational activities;
  • Draft regulatory documents, review original documents provided by each department;
  • Compile and perfect the submission package and track the CDE decision;
  • Build, publish the submission with eCTD format when applicable;
  • Adhere to quality control procedures and standards related to submission publishing to ensure Regulatory compliance;
  • Adhere to the appropriate use of document management systems, publishing and validation tools, through the use of working practices and quality control steps;
  • Establish and maintain regulatory WIs and SOPs as a writer and trainer;

Qualifications:

  • At least 2-year working experience in regulatory affairs.
  • Bachelor or above in pharmacy, clinical pharmacology or related field.
  • Acquainted with China and US drug registration regulation and ICH guideline.
  • Familiar with eCTD system and software
  • Chinese and English (proficient), computer skill: word, excel, power point.

Internal-External Relations
Internal: Each function lines in HMP.
External: Vendors