Chantay Moore Email & Phone Number

Culver City, California, United States

Serve as Global Regulatory Lead to Support Product Safety and Regulatory Affairs (PSRA) and Intl Business Development (IBD) teams in Intl expansion. Liaise with distributors and Intl health authorities, create country specific dossier and documentation for product registration. Initiate and execute legal documentation specifically required for regulatory purposes - NDA, POA, CFS, and GMP

Los Angeles Metropolitan Area

Provide Quality and regulatory compliance consulting services to companies that manufacture and distribute cosmetics and OTC drugs for domestic and international markets. Develop QMS compliance policies and procedures, GMP/GLP auditing and training, Audit reporting and CAPA support, Drug manufacture licensing and registration, Build and maintain product portfolio and dossier used to support international regulatory registrations and notifications, Liaise with distributors, responsible parties, and regulatory agencies on clients behalf to ensure product registrations and notifications are satisfied within project timing, Review formulas and labeling for regulatory compliance, Evaluate and advise on testing necessary to support product claims and more

Foothill Ranch, Ca

Responsible for staffing and building regulatory team from ground floor. Train and coach regulatory, R&D, and marketing to collaborate from conception of project to ensure understanding of regulatory requirements and budget needs. Performed global assessments on each formula to ensure all raw materials are approved for use and restrictions are adhered to during development. Worked with Operations and Supply Chain to create a process for regulatory inclusion in determining feasibility for changes. Built Product Information Files (PIF) of each product to include all necessary documentation and formatting and testing required to support international regulatory registrations. Development and execution of global regulatory strategies and registrations and reporting for cosmetic, OTC drugs, and Nutra products in Canada, California (SB312), Australia, New Zealand, Indonesia, Switzerland, EU and UK. Liaised with responsible party and safety assessors to ensure registrations are completed to support marketing timelines. Worked with all corporate offices, domestic and international to ensure the correct product information, claims and labeling are compliant for each country website. Created globally compliant Ingredient lists to minimize label production and reduce budget spending. Reviewed and approved all product labeling and artwork. Collaborated with marketing education team to ensure all education documents, product knowledge guides and stage scripts are regulatory compliant and offering them suggestive language to soften certain claims to reduce regulatory risk. Stayed informed of all regulatory changes in the pipeline, both domestic and international, and communicated expected impact to brand stakeholders.

Lead process to get product portfolio completely divested from previous stockholder during acquisition. Worked to finalize and complete ongoing investigations and resolve existing QA issues. Executed technical transfer of 80% of product portfolio due to the unexpected closure of the contract manufacturer. Directed daily operations of the quality and packaging teams. Responsible for the total creation and execution of Quality Systems and Quality Operations for newly acquired pharmaceutical skin care start-up. Developed QMS systems per 21 CFR, Parts 210, 211 to include writing, training, and execution of standard operating procedures (SOPs) and defining processes for handling product complaints, OOS investigations and Corrective actions. Hired, trained, and cultivated industry experienced departmental support to foster a collaborative team culture. Collaborate with product development and marketing to ensure critical launch initiatives are met and result in safe effective products for market. Support product development with technical operations to ensure compliance and quality of raw materials and validated processes. Maintained robust stability and packaging compliance program to support product shelf life. Maintain complete product dossier and drug files to support international regulatory registrations. Aggressively identified opportunities to proactively assure compliance to applicable regulations both domestic and international. Audit and evaluate progress of contract manufacturers, 3rd party labs, and logistics to ensure they meet corporate compliance standards as well as compliance to applicable regulations. Streamline processes to better support operations and inventory resulting in timelier product release.

Glendale

GMP consulting practice

Plan, execute and manage quality systems and regulatory affairs and activities including CAPA, document control, stability programs, annual drug review, and training systems ensuring compliance with FDA, EPA and company standards. Responsible for writing, reviewing and revising company SOP’s, and writing and execution of company validation program. Responsible for leading customer and regulatory audits, filing applicable response and management of corrective actions. Also responsible for leading product development team from conception to pilot ensuring new formulations comply with applicable standards, efficacy, safety, and substantiation of claims to support marketing group. Maintain licenses, product registrations, and drug listings.

Plan, execute and manage quality systems and regulatory affairs and activities including CAPA, document control, stability programs, annual drug review, and training systems ensuring compliance with FDA and company standards. Responsible for writing, reviewing and revising company SOP’s, and writing and execution of company validation program. Responsible for leading customer and regulatory audits, filing applicable response and management of corrective actions. Also responsible for leading product development team from conception to pilot ensuring new formulations comply with applicable standards, efficacy, safety, and substantiation of claims to support marketing group. Maintain licenses, product registrations, and drug listings.

Mba

Chemistry