- 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;
- 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: Each function lines in HMP.