Senior Manager to Associate Director, CMC RA

Senior Manager to Associate Director, CMC RA

Job Description:

• 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
• Effective Teamwork
  • Actively participate in team working
  • Share best practice examples & learning with the team and global colleagues

Job Qualifications

• Education
  • Bachelor or above in Pharmacy, Medical, Biology or related field
• Skills
  • 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
• Experience
  • > 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.

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