Job Summary:

·      Collection information and prepare the documentation to support the HGRAC application and submission.

·      Provides support and assistance in terms of reviews data for accuracy and compliance to applicable SOPs and regulations. Maintains and expands knowledge of regulatory requirements, SOP requirements, and client requirements.

·      Responsible for communicating with internal teams to resolve any issues during the submission process.

Essential Job Duties:

·      Assists to the collect information, prepare documentation and upload to complete the HGRAC submission.

·      Possesses a strong understanding of HGRAC policy and departmental processes.  And proactively communicates with internal teams to resolve any issues during the submission process.

·      Follow up the HGRAC application status of the project and the problems during the application process, if needed, to prevent recurring citations, problems, or errors.

·      Prepares and supports HGRAC inspections.

·      Assisting a working knowledge of client SOPs and requirements. Ensure that the data reviewed comply with applicable departmental procedures and HRGAC policies.

Requirements (Experience, Education, Qualifications and Skills)

Experience:

• The candidate with 2 years’ experience about HGRAC submission in the Pharmaceutical industry in Regulatory Affairs or Drug Development is preferred.

Education:

• Bachelor’s Degree in Life Sciences or equivalent, possibly with a higher qualification.

Skill:

• Required outstanding communication and negotiation skills.
• Be able to read, write and speak English proficiently.