Sothavy Ton Email & Phone Number

Continuation to participate in activities to ensure compliance with worldwide regulatory requirements. Provide regulatory support in system implementation projects, postmarket and labeling compliance, specifically:• Designed and developed Project Management system (Quickbase) to facilitate labeling requests, custom projects, teams & data• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products•… Show more Continuation to participate in activities to ensure compliance with worldwide regulatory requirements. Provide regulatory support in system implementation projects, postmarket and labeling compliance, specifically:• Designed and developed Project Management system (Quickbase) to facilitate labeling requests, custom projects, teams & data• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly• Maintain current knowledge of relevant regulations, including proposed and final rules• Oversee documentation efforts through regulatory gap assessments to ensure compliance with domestic and international regulations and standards• Develop and maintain standard operating procedures or local working practices• Supports collection of data for Unique Device Identification system to adequately identify medical devices sold in United States (GUDID), Europe (Eudamed) and other applicable global countries• Supports release of Finished Good Parts to fulfill global orders in SAP system• Supports implementation activities for quality system projects• Keep abreast of new or developments in various regulations and advise Regulatory Affairs management as necessary.• Train key personnel on new regulatory operational policies, processes and procedures.• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.• Data Extraction and organization of data• Utilize databases (SAP, Oracle, Excel, PLM)• Manage large data transfersObtaining and delivering controlled labeling documents• Labeling and IFU verifications for medical devices• Ad hoc projects Show less

Participate in activities to ensure compliance with worldwide regulatory requirements. Provide regulatory support in system implementation projects, postmarket and labeling compliance, specifically:• Support product registration• Participate in development activities and support product development teams to ensure compliance with regulatory requirements.• Prepare submissions and manage any additional information Requests from the agencies.• Participates in SQA/Manufacturing… Show more Participate in activities to ensure compliance with worldwide regulatory requirements. Provide regulatory support in system implementation projects, postmarket and labeling compliance, specifically:• Support product registration• Participate in development activities and support product development teams to ensure compliance with regulatory requirements.• Prepare submissions and manage any additional information Requests from the agencies.• Participates in SQA/Manufacturing changes with assessments and submission as applicable.• Participates in development teams and provides input to assure that worldwide regulatory requirements including EU MDR regulations and standards are incorporated in the product development process and design/ manufacture of the products.• Collaborate with RA Country Managers to identify country-specific requirements relevant to product development projects such as special testing and labeling requirements.• Generate master submission documents to support worldwide submission activities.• Produce subsequent submissions (Annual Reports, Additional Information Requests, etc.) to facilitate the maintenance of existing approvals.• Participate in the engineering change order process, by reviewing engineering and manufacturing document release and changes with Agile PLM.• Supports implementation activities for quality system projects.• Keep abreast of new or developments in various regulations and advise Regulatory Affairs management as necessary.• Train key personnel on new regulatory operational policies, processes and procedures.• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.• Data Extraction and organization of data• Utilize databases (SAP, Oracle, Excel, PLM)• Manage large data transfersObtaining and delivering controlled labeling documents• Labeling and IFU verifications for medical devices• Ad hoc projects Show less

Write, review, collect, coordinate and/or oversee projects and tasks assigned to team members, and facilitate peer reviews and/or prepare regulatory documentation for submission to regulatory agencies or to commercial partners and/or clients, including but not limited to label or copy reviews, claim substantiation, formula reviews, due diligence, SOPs and templates, safety plans, investigation reports, study protocols, GRAS/NDI dossiers, 483s, Warning Letters, any final reports and other… Show more Write, review, collect, coordinate and/or oversee projects and tasks assigned to team members, and facilitate peer reviews and/or prepare regulatory documentation for submission to regulatory agencies or to commercial partners and/or clients, including but not limited to label or copy reviews, claim substantiation, formula reviews, due diligence, SOPs and templates, safety plans, investigation reports, study protocols, GRAS/NDI dossiers, 483s, Warning Letters, any final reports and other associated data. • Team participation and project/task ownership as well as assignment and general updating, management support. • Direct support for clients across all project, tasks and subtasks types in each regulatory department within the company. • Lead projects and outline remediation plans related to quality system analysis, warning letters, 483s and etc. • Lead project setup and scope defining, task naming, project protocols as applicable and support for design and improvement to project management solution and related services such as Quickbase. • Organize regulatory information, track and control documentation, timelines and provide input in accordance to daily operating practices.• Establish budgets and timelines to meet project milestones, endpoints and deliverables. Show less

• Write, review, collect, coordinate and/or oversee projects and tasks, and prepare regulatory documentation for submission to regulatory agencies or to commercial partners and/or clients, including but not limited to label or copy reviews, claim substantiation, formula reviews, due diligence, SOP’s and templates, safety plans, investigation reports, study protocols, final reports and other associated data as directed. • Travel as needed to clients’ facilities or other locations to directly… Show more • Write, review, collect, coordinate and/or oversee projects and tasks, and prepare regulatory documentation for submission to regulatory agencies or to commercial partners and/or clients, including but not limited to label or copy reviews, claim substantiation, formula reviews, due diligence, SOP’s and templates, safety plans, investigation reports, study protocols, final reports and other associated data as directed. • Travel as needed to clients’ facilities or other locations to directly support assigned projects or tasks, or other company activities• Maintain timely compilation of billable time and materials for any assigned work or licenses and/or registrations. • Work with the executive management to build and manage departmental teams within the company to accomplish company defined goals and financial objectives. • Maintain regulatory files/database in good order; help establish and maintain project management system for tracking changes in documents submitted to agencies or partners. • Lead and/or support the review of formulas, labeling practices and labels for compliance with regulatory requirements e.g. structure-function claims and other allowable claims categories in the US or other designated countries. • Responsible for accomplishing/managing all assigned client tasks through team members, client personnel and/or other contracted third parties. • Maintain current knowledge of FDA, FTC, USDA and other international regulations, guidance and standards applicable to client products. • Actively participate in evaluation of regulatory changes affecting compliance of documentation, product(s), process(s), methodologies, etc. • Provide team/client leadership with guidance on compliance matters and regulatory operations in respect to known strategies, activities or operations.• Participate in research of regulatory issues and dissemination information to team members for communications with client or partners as required. Show less

Torrance, Ca

• Organize inter- and intra-department meetings to discuss identified issues and projects• Organize meetings with vendors (raw material suppliers, distributors, contract manufacturers)• Maintain vendor contact list• Collaborate with vendors to resolve technical issues• Train vendors on current Herbalife requirements pertaining to raw materials• Train departments on management of raw materials and agile changes for documentation• Gather raw material documents as… Show more • Organize inter- and intra-department meetings to discuss identified issues and projects• Organize meetings with vendors (raw material suppliers, distributors, contract manufacturers)• Maintain vendor contact list• Collaborate with vendors to resolve technical issues• Train vendors on current Herbalife requirements pertaining to raw materials• Train departments on management of raw materials and agile changes for documentation• Gather raw material documents as necessary• Developed/Design potential new PPM agile task for Technical Support Analyst for process improvement/metrics• Collaborate with Agile support to develop, implement and trainWeb-interface portal with agile for document collection• Maintain, manage and route changes (ECR, MCO, ECO, EC) to manage raw materials and their lifecycle revisions• Coordinate approvals from interimdepartments for routed changes (ECR, MCO, ECO, EC)• Lead in reviewing and approving deviations related to skus/formulas for raw material substitution Show less

Torrance, Ca

• Gather and maintain controlled documentation/information for raw materials and assure that certificates are current (e.g. Kosher, Halal, IP (Identity Preserved), COA, (Certificate of Analysis), etc and upload in Agile database.• Review and revise existing raw material specification to reflect accuracy and appropriateness. Compares testing requirements versus compendia standards (USP, NF, FCC and etc) and recommends any other testing that may be appropriate.• Review and proposed… Show more • Gather and maintain controlled documentation/information for raw materials and assure that certificates are current (e.g. Kosher, Halal, IP (Identity Preserved), COA, (Certificate of Analysis), etc and upload in Agile database.• Review and revise existing raw material specification to reflect accuracy and appropriateness. Compares testing requirements versus compendia standards (USP, NF, FCC and etc) and recommends any other testing that may be appropriate.• Review and proposed testing requirements for new and existing raw materials with ProjectManagement, R&D, Global StrategicSourcing, Global Licensing, Quality Control and Global Product & Science Safety to assure appropriateness.• Manage raw material change orders ECO (Engineering Change Order) and MCO (Manufacturing Change Order) in Agile. Gather the right approvals and implement in a timely manner.• As needed, discusses any specific country testing requirements (USP, Ph Eur or equivalent) with Global Licensing.• Collaborate/Interacts with different departments, contract manufacturers and raw material suppliers regarding issues with existing and new raw materials to assist in problem resolution; maintain vendor contacts• Periodicallymonitors raw material testing performed by suppliers/vendors.• Review Deviations in relation to raw material supplier use and qualification for comparability• Organize and maintain spreadsheets for projects and work tracking• Evaluate supplier qualification in use of preliminary and master formulas• Review details of labels using approved master formula and/or the most current FSF to verify information in regards to label claims in the nutrition panel, ingredients listed, servings size and any claims in writing needed to be confirmed. Show less

City Of Industry, Ca

• Temporary Contract through Aerotek Scientific• Conducted basic microbiology tests and analysis (Coliform, Aeorobic bacteria and yeast and mold)• Performed line checks on the food samples (weight, packaging, and metal)• Analyzed impact of raw material on food production and use of SAP program• Participated in success with certification of Safe Quality Foods (SQF) audit and recertification• Performed physical tests (viscosity, PH, sugar (brix), fat, solid, salt and titration… Show more • Temporary Contract through Aerotek Scientific• Conducted basic microbiology tests and analysis (Coliform, Aeorobic bacteria and yeast and mold)• Performed line checks on the food samples (weight, packaging, and metal)• Analyzed impact of raw material on food production and use of SAP program• Participated in success with certification of Safe Quality Foods (SQF) audit and recertification• Performed physical tests (viscosity, PH, sugar (brix), fat, solid, salt and titration acid analysis) on raw and finished material Show less

Irvine, Ca

• Temporary Contract through LabSupport• Approved, Review documents (SOPs and change orders) which followed GMP Practice, FDA Regulations and RegulatoryCompliance; includes SOP formatting and writing; recommend revisions in accordance to compliance• Implemented and placed effective dates on documents (SOPs and change requests) to provide procedural impact to company• Analyzed impact of associated documents in relation to compliance, CAPAs, deviations and quality input• Part… Show more • Temporary Contract through LabSupport• Approved, Review documents (SOPs and change orders) which followed GMP Practice, FDA Regulations and RegulatoryCompliance; includes SOP formatting and writing; recommend revisions in accordance to compliance• Implemented and placed effective dates on documents (SOPs and change requests) to provide procedural impact to company• Analyzed impact of associated documents in relation to compliance, CAPAs, deviations and quality input• Part of remediation team for TevaDoc(Electronic Validated Documentation System) upgrade by providing suggestion of compliance and user requirements in regards to regulatory standards• Assisted departments with re-certification process, remediation or method transfer protocols Show less

La Mirada, Ca

• Performed tasks in absence of QualityManager, which followed GMP Practice and Regulatory Affairs• Created procedures (SOPs) for company that followed regulation under the Pharmacopeia and Good Manufacturing Practice• Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology with SOP creation.• Maintain records and files of work and revisions of documentation, SOPs and Change requests.• Edit… Show more • Performed tasks in absence of QualityManager, which followed GMP Practice and Regulatory Affairs• Created procedures (SOPs) for company that followed regulation under the Pharmacopeia and Good Manufacturing Practice• Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology with SOP creation.• Maintain records and files of work and revisions of documentation, SOPs and Change requests.• Edit, standardize, or make changes to material prepared by other writers or establishment personnel.• Review published materials and recommend revisions or changes in scope, format, content, and methods of reproduction and binding; Select photographs, drawings, sketches, diagrams, and charts to illustrate material• Compiled analytical results (Certificate of Analysis)• Initiated/ closed batch records for production of final products• Performed internal audits on shipping records, Bill of material (Product specifications, COA, micro results, chemical results,water results, pesticide and ingredient supply access), release product, issue hold and release tags, batch records, certificate of analysis, standard operating procedures (SOPs) and compiled microbial and chemical data• Ran spectroscopy and physical tests (viscosity, particle size, moisture/ LOD, bulk density) on finish and raw material and basic data input• Followed up with CAPAs in relation to a deviated response; providing more efficient procedural operations Show less

Master'S Degree, Project Management

Bachelor Of Science (B.S.), Molecular Biology And Biotechnology