Job Responsibilities:

• Supporting all regulatory activities of the HBM products；

• Ensure timely preparation of filing dossiers;

• Ensure that the format of filing dossiers comply with applicable guidelines, ensure dossiers quality and consistency;

• Collecting and compiling submission related reference documents and materials.

MANDATORY KNOWLEDGE – SKILLS AND ABILITIES

• Bachelor's degree major in medical, pharmacy, pharmacology, biochemistry or chemistry or relevant discipline.

• Basic knowledge of biological product development process; basic knowledge of biopharmaceutical manufacturing is preferred.

• Strong interpersonal and communication skills and demonstrate that open-minded personality that is willing to accept the ever-changing regulatory environment.

• Skilled in MS Office package such as Word, Excel, Power Point.

• Skilled in English reading, writing, listening comprehension and fluent in speaking

• Rigorous and precise in execution; also a team player.

上班地址：科技大学东1门41号楼305