Wen Xuan Sim Email & Phone Number

Penang, Malaysia

• 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.• Maintain product registration database for Hong Kong, Taiwan, South/East Asia, and India Subcontinent & Distribution countries and track regulatory department metrics.• Manage communication related to vigilance issues for assigned countries to ensure compliance with regulations and support the success of the organization.

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. • Establish, maintain, review and approve documents/records to ensure compliance to GMP/ISO requirements. • Conduct HLearn training programs where necessary.• Responsible in release of product to/from sterilization and to make disposition of the inspected component and product.

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