Description

Summary of Job Responsibilities:
Lead one COE group,
1.    Execute regulatory submission activities for CTA & NDA/BLA & variation during clinical trials and timely filing across TAs.
2.    Execute QC testing related activities for CTA & NDA/BLA.
3.    Support HA consultation meeting and HA query response.
4.    Build up good collaboration with key stakeholders in local, regional, and global organizations.

Dimensions of Job:
1.    Implement regulatory submission for CTA & NDA/BLA & variation during clinical trials across TAs ensuring all activities following company procedures and local regulations.
2.    Execute QC testing related activities for CTA & NDA/BLA ensuring all activities following local regulations and company procedures.
3.    Support HA consultation meeting related activities and HA query response following local regulations and global procedure
4.    Work well with key stakeholders in local, regional, and global organizations.

Principal Accountabilities of Job:
1.    Collaborate with local project team, regional and global key stakeholders to prepare dossier and execute submission for CTA & NDA/BLA & variations during clinical trials. Conduct QC testing and support HA consultation meeting related activities and HA query response ensuring timely delivery.
2.    Coordinate internal discussion to update local procedures to meet global procedures and local regulations, guidelines if applicable.
3.    Develop and improve internal process for operation excellence.
4.    Actively lead or involve in review and revision of regulations, guidelines if applicable.
5.    Conduct related trainings for operation excellence.
6.    Credo based behavior with regulatory compliance.

Key Performance Measures: 
1.    Coordinate group members to achieve timely regulatory submission delivery and related activities with high quality. 
2.    Keep compliant with company procedures and local regulations.
3.    Good communication skill, risk management mindset and learning agility.
4.    Others:  Escalate potential issue to line manager when applicable.

Qualifications

1.    Master’s degree in chemistry, pharmaceutics, biology, or a related life-science discipline. 
2.    Minimum of 3 years’ regulatory affairs submission experience in a multi-national pharmaceutical company and minimum of 2 year people leading experience is preferred. 
3.    Strong oral & written communication skill; ability to work under pressure. 
4.    In-depth knowledge of regulatory environment, regulations and guidelines. 
5.    Experienced in working with cross-functional team for submission strategy and implementation.
6.    Proficiency in verbal and written English; good presentation skill, good computer skill.