Wen Xuan Sim Email & Phone Number

• Compile technical documents and provide guidance for local regulatory submissions in Hong Kong, Taiwan, South/East Asia, and India Subcontinent countries.
• Review proposed labeling changes to determine regulatory impact on existing certifications and registrations.
• Collaborate with cross-functional teams, including RA staff, clinical staff, and program managers, to develop regulatory approval strategies for products and prioritize projects.
• Conduct training programs to educate employees on regulatory requirements and good regulatory practices.
• Review new regulatory guidance and participate in the implementation of programs to support compliance.
• Communicate with customers to respond to regulatory concerns/questions.

Malaysia

• Conducts internal or external audits as assigned to ensure compliance to company quality system requirements.
• Manages the process to gather and communicate quality systems Key Performance Indicators across the organization.
• Coordinate and chair the MRB meeting and review all the items located in MRB/QUAR with board members to investigate and determine the disposition for the NC items in weekly basis.
• Manage and lead NCE program, implementing global NCE policies.
• Review and approve Agile workflows, and any other documentations.
• Supporting corporate labeling team on the review and process of ECOs related to HQ/EUMDR project and blood center MDR labeling change.

Chiayi City, Taiwan, Taiwan

• Assist staff with daily, routine library operations.
• Providing book borrowing and book returning services.
• Providing answers to directional questions and answered the phone inquiries.
• Shelved books.
• Assisted members of the university community find needed information.

Bachelor'S Degree, Microbiology, Immunology And Biopharmaceuticals, Gpa 3.83 / 4.0

Activities and Societies: 1. Activities Department of National Chiayi University Music Festival (Sept 2019 - Dec 2019) • Successfully.

Malaysian Higher School Certificate (Stpm), Science, Cgpa 3.00 / 4.00

Malaysian Certificate Of Education (Spm), Science, 10 A