Adherence to Innoforce and industry code of conduct, ethics and good regulatory practices including regulatory and other required RA SOPs.
Align with the values and vision of Innoforce
Maintain regulatory compliance (CMC) with Local legislation, Global regulatory policies
Maintain company confidentiality (i.e. intellectual property, product information and strategic information)
Follow SOP requirements especially on documentation
Implement regulatory enhancement in achieving rapid and high pass rate IND approval and facilitating rapid growth of CDMO business.
Establish RA workflow, regulatory training of CMC development
Coordinate with key project stakeholders (PD/AD/QC/MFG/QA etc.) to achieve rapid/ high quality submissions and approvals
Prepare and produce high quality regulatory submissions including CTD/eCTD/ DSUR
Monitor registration process and promptly report whenever necessary
Actively communicate with CDE reviewers for any potential technical discussion and panel meeting for both Innoforce and client’s project
Effectively manage the local and global regulatory support systems/information to ensure good coordination for all stakeholders
Maintain and update local and global regulatory support and information systems
Support BD for pre-sales regulatory inquires if needed
Communicate changes to regulatory status to all stakeholders
Provide appropriate support at project base
Monitor local regulatory environments and address for key stakeholders with analysis, support to exert regulatory influence through company initiatives
Maintain up-to-date knowledge of local regulatory environment
Communicate changes of local regulatory environment
Provide best guidance with necessary training
Assist Issue Management.
Provide detailed information of affected project when troubleshooting is related to regulatory
Undertake assigned follow-up action where necessary
Establish Master File
Organize to provide confidential detailed information for master files about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs or material when applicable.
Maintain master file status is up to date
Issue letter of authorization (LOA) for citing of approved project
Ensure on timely response to FDA inquiring or comments
Actively participate in team working
Share best practice examples & learning with the team and global colleagues
Bachelor or above in Pharmacy, Medical, Biology or related field
Possess a high degree of honesty with a track record built on success stories and sound ethics, have a proven track record from top pharma/CDMO company is a plus.
Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with some key customers.
Project management primary level skill
Chinese and English (proficiency level)
Computer skill: word, excel, power point
> 3 years experience in manager position or >5 years in specialist position.
Experience in cell and gene therapy product development, or manufacturing and QA/QC is preferred.