(Senior) Manager, Regulatory Affairs - Quality & Compliance

Auris Health

Auris Health

Legal, Quality Assurance
Shanghai, China · Beijing, China
Posted on Thursday, August 31, 2023
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Summary of Job Responsibilities:
1.    Build RA Quality & Compliance culture. Drive RA Quality & Compliance excellence to align with global standard and local regulation.
2.    Manage RA SOP,WI,Job-aids and keep it updated to align with global standard and real practice
3.    Lead audit with RA involved and lead RA team well prepared and develop CAPA plan if needed
4.    Manage Product Master File and support PMF consistency check

Dimensions of Job:
1.    Regulatory compliance oversight and support company quality management system building. Drive regulatory compliance process continuous improvement
2.    Lead gap assessment for local and global SOP/WI, local Job-aids to align with global standard, local regulation as well as real practice
3.    Liaise with company quality functions including but not limited to XJP Commercial Quality, BRQC China R&D Quality Management, GRA Quality Management, AP compliance etc.
4.    Build process to manage the Product Master File cooperating with local and global cross functions and support PMF consistency check
5.    Organize and provide inputs for the projects with RA quality related, when applicable

Principal Accountabilities of Job:
1.    Regulatory compliance oversight and support Quality Management System building, including development of RA compliance plan and quality metric, and contribution to quality system of related quality functions at local and global level
2.    Drive internal regulatory process development to align with global standard and local regulation 
3.    Lead audit for RA department including LOC internal audit,BRQC audit and JJRC audit etc. Drive development of CAPA to address observations if any.
4.    Drive RA risk assessment development and periodically review, identify potential risk and develop mitigation plan to ensure regulatory compliance 
5.    Develop Product Master File process, support consistency check
6.    Credo based behavior with regulatory compliance excellence

Key Performance Measures: 
1.    RA quality & compliance metrics are well defined and implemented 
2.    Ensure local SOP/WI/Job-aids fully align with global standard and local regulation
3.    No critical finding for all audits that are performed in RA department.
4.    Strong cross-team connection and leadership


Qualifications & Competencies: 
1.    A bachelor’s degree major in chemistry, pharmaceutics, biology or a related life-science discipline. A master’s degree or above is preferable
2.    At least 5 years of working experience.   At least 2 years’ experience in management role is preferred.
3.    Strong oral & written communication skill; good leadership capability and ability to work under pressure. 
4.    In-depth knowledge of regulations and guidelines for regulatory affairs
5.    Proficiency in verbal and written English; good computer skill, good presentation skill.