Regulatory Affairs Specialist/Senior Specialist

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PRIMARY FUNCTION

  1. Regulatory Affairs

MAJOR RESPONSIBILITIES, AND DUTIES:

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

Qualifications:

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

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