Gary Tung Email & Phone Number

Thousand Oaks, Ca, Us

Clustered Country Quality Lead of Hong Kong, Macau, Vietnam and Philippines.

Gb

Regulatory Affairs: o product registration, maintenance and change impact assessmento Ensure regulatory records system up to dateo Promotional material review and approvalQuality Assuranceo Local QMS development and ensure operation records properly filed. o Managing third party supplier and auditingo Handle product release, complaint, recall and CAPA closureProduct Vigilanto Monitor adverse event and reporting according to global timelineo Review and assess adverse event in all channels Otherso Conduct training for the internal staff and budget planning for entire activities

Heidenheim, Baden-Württemberg, De

● Direct RA and QA handling for Hong Kong and Taiwan market while support distribution model for South Korea and Southeast Asia countries.● Continual monitoring, analysis and evaluation of the relevant national regulatory environment and evaluate the impact to APAC countries for regulatory changes ● Provide regulatory strategy in product registration, renewal and variation and along to business plan. Manage APAC regulatory database and registration dossiers.● Printed promotion materials review and approval.● Review and work with global labeling team to develop countries product labels to meet regulatory requirements and marketing strategy. Provide insights and advice for contents, translation and term used to facilitate market access and registration.● Post Market Surveillance monitoring and handling in APAC region such as complaint, field action, CAPA and adverse reporting.● Managing and monitoring outsourced regulatory parties and distributor in APAC countries for registration and quality requirement.● Regulatory Assessment/ Auditing of third parties (e.g. suppliers, subcontractors, service providers) including regulatory assessment of relevant contracts ● Regulatory and Quality training of employees (e.g. complaint handling, vigilance system) ● Prepare, review and implement QMS documents.● Budget planning and cost monitoring for RAQ APAC region.● Provide support to tender applications● Local compliance officer for internal operation such as review the HCP engagement and sponsorship requests to make sure their adherence to the SOPs and Code of Practice.

Lake Forest, Il, Us

• In-country quality management system as well as ensuring compliance in relation to the supply, handling, storage and distribution of company products which include pharmaceutical products and medical devices.• Local inbound product compliance checking, redressing preparation and release handling• Complaint handling, product inspection and distributor monitoring• Liaise between corporate, regional, local and regulator for proper product field action plans.• Implement and maintain local Standard Operating Procedures (SOP’s) in line with regional • Handle deviations including initiating CAPA, organizing root cause investigation, definingeffective action plan, implementing and closure of CAPA• Quality System Coordinator for Asia New Product Launch - Compliance checking for the impact assessments of new products launching in the Asia Market and manipulate SAP QMS function.• Internal GMP/ISO Auditor for distributor and supplier • Provide training to local team and support to other ad-hoc projects and duties as required• Interim Regulatory Affairs Activities for Hong Kong and Macao

New York, New York, Us

• Maintain the product registration record in DoH and HA. Products range include Central Nervous System, men and women healthcare. • Liaise with global colleagues, local commercial and DoH for changes and approval.• Handle documents for tender submission and follow up enquires from CPO.• Storage room calibration and setup as per local wholesale dealer license requirement• Streamline operation process with other departments

New York, New York, Us

• Handle Product Quality Inspection and Release in Hong Kong and Macao for all Pfizer Pharmaceutical products• Monitor product repackaging process in Hong Kong • Monitor distributor and warehouse quality • Implement quality plan and maintain quality system in Hong Kong and Macao office• Handling product complaint and recall• Quality contact point for global • SAP quality management and staff training

• Clean room facilities monitoring , developing production line and GMP documents. Production process operation.• Validation process development and operation for equipments such as steam sterilizer and cold room• Warehouse management and handling inventory system.

Master Of Science (Msc), Biotechnology

Bachelor'S Degree, Biochemistry