Sr. Regulatory Affairs Specialist
Resume:
Jessica Cortez
Cosmetic Regulatory Affairs Professional
Palmdale, CA 93550 661-***-**** ************@*****.***
Professional Summary
Experienced Regulatory Specialist working with third party manufacturing in the cosmetics industry.
Worked with skin care, OTC and color cosmetics. Able to liaise with product development and R&D
to provide necessary regulatory support. Review of regulatory matters related to company formulas,
materials, or procedures, to ensure compliance. Proficient in fast paced, customer driven environment,
with strong organizational and communication skills.
Willing to relocate: Anywhere
Work Experience
Senior Regulatory Affairs Specialist
Obagi Cosmeceuticals Long Beach, CA
January 2025 to Present
Manage global product registration across regions including EU, UK, Turkey, Iraq, Kazakhstan, Israel, UAE, Saudi Arabia,
Tunisia, Jordan, Colombia and Guatemala
Review product formulations, labeling and marketing claims to ensure compliance with applicable regulations
Prepare and maintain regulatory documentation and submission for cosmetics and OTC products
Coordinate Product Informatiom Files (PIFs), safety assessments, and technical dossier
Partner with R&D and Contract manufacturers to support compliant product launch
Coordinate with regulatory authorities, third party manufacturers and internal stakeholders
Support internal audits and ensure ongoing compliance with global regulatory standards
Sr. Regulatory Specialist
ZO Skin Health, Inc. Irvine, CA
March 2022 to December 2024
Perform regulatory assessments of formulations and labeling for various regions including but not limited to Canada,
EU, ASEAN, Japan and for various product types including cosmetics and OTC drugs.
Review chemical ingredients and determines the warning labels for each product.
Review claims for marketing collateral and website content and determines acceptability.
Assists in monitoring regulations and standards for changes and assesses impact.
Communicates significant issues or developments identified during regulatory activities and provides recommended
process improvements to management.
Coordinates, compiles Regulatory documents that are intended to be submitted to FDA and other Regulatory Agencies
as required including international registration documents for cosmetic and drug products.
Evaluates proposed product formula modifications for global regulatory impact.
Liaises with international distributors and partners plus internal departments to request, coordinate and provide
regulatory information.
Maintains documentation and related systems necessary for efficient operation of the department.
Provide advice and support to junior regulatory specialists.
Sr. Regulatory Specialist
ZO Skin Health, Inc. Irvine, CA
March 2022 to December 2024
Perform regulatory assessments of formulations and labeling for various regions including but not limited to Canada,
EU, ASEAN, Japan and for various product types including cosmetics and OTC drugs.
Review chemical ingredients and determines the warning labels for each product.
Review claims for marketing collateral and website content and determines acceptability.
Assists in monitoring regulations and standards for changes and assesses impact.
Communicates significant issues or developments identified during regulatory activities and provides recommended
process improvements to management.
Coordinates, compiles Regulatory documents that are intended to be submitted to FDA and other Regulatory Agencies
as required including international registration documents for cosmetic and drug products.
Evaluates proposed product formula modifications for global regulatory impact.
Liaises with international distributors and partners plus internal departments to request, coordinate and provide
regulatory information.
Maintains documentation and related systems necessary for efficient operation of the department.
Provide advice and support to junior regulatory specialists.
Regulatory Affairs Consultant
Regulatory Affairs Consultant
January 2021 to March 2022
Manage product registrations (EU and UK).
Managed Brands Color Pop, Young Blood Minerals, Bright Innovations
Develop and maintain regulatory/technical documentation for new/existing products to meet regulatory requirements
and customers needs.
Coordinate with manufacturer and responsible person (RP) for the required documents for the PIF and submitting
documentation for safety assessments as appropriate (e.g. customer formulas raw material documents, safety testing
for European distribution.)
Ensure required/voluntary registrations are completed for products
Manage communication between raw material supplier and manufacturer for raw material documentation to complete
registration and formula reviews.
Successfully registered multiple projects in the EU and UK.
Regulatory Affairs Consultant
January 2021 to March 2022
Manage product registrations (EU and UK).
Develop and maintain regulatory/technical documentation for new/existing products to meet regulatory requirements
and customers needs.
Coordinate with manufacturer and responsible person (RP) for the required documents for the PIF and submitting
documentation for safety assessments as appropriate (e.g. customer formulas raw material documents, safety testing for
European distribution.)
Ensure required/voluntary registrations are completed for products
Manage communication between raw material supplier and manufacturer for raw material documentation to complete
registration and formula reviews.
Successfully registered multiple projects in the EU and UK.
Regulatory Affairs & Document Control Administrator
New Look Cosmetics Chatsworth, CA
April 2019 to August 2021
Provide support required for successful launch of new and existing products.
Manage product registrations (EU, South America, Japan, Canada, Australia, Dubai etc.). Coordinate product profiles
according to market requirements.
Update and maintain product profiles accordingly to manufacturing. Assist with product clearance.
Maintain master documents
Review and prepare master files for audits
Review Marketing Claims
Create IL s and Q&Q s
Regulatory Affairs & Document Control Administrator
New Look Cosmetics Chatsworth, CA
April 2019 to August 2021
Provide support required for successful launch of new and existing products.
Manage product registrations (EU, South America, Japan, Canada, Australia, Dubai etc.). Coordinate product profiles
according to market requirements.
Update and maintain product profiles accordingly to manufacturing. Assist with product clearance.
Maintain master documents
Review and prepare master files for audits
Review Marketing Claims
Create IL s and Q&Q s
Regulatory Affairs Manager
Cosmetic Technologies Newbury Park, CA
March 2015 to November 2020
Maintained as required.facility and product registrations (FDA, CA OTC and Cosmetic, CA Organic).
Develop and maintain Regulatory/technical documentation for new/existing products to meet regulatory and customer
needs.
Create finished good/product MSDS
Assist with product clearances, including coordinating safety (e.g. RIPT, micro challenge) and efficacy tests (e.g. SPF)
with external/internal test. Assist laboratories, and submitting documentation for safety assessments as appropriate
(e.g. customer formulas for European distribution.)
Ensure required/voluntary registrations are completed for products
Provide Marketing and customer regulatory support to extend products into new markets.
Provide Marketing with regulatory support in developing product profiles (e.g. ensuring claims are appropriate for
cosmetics, and can be supported by formula).
Ensure that safety/regulatory requirements are met for products prior to launch.
Review artwork for finished goods.
Issue and maintain technical/regulatory documentation and files.
Implement and document changes on the Basic Change Log and ECNs related to raw materials and formulas.
Provide Marketing/Accounts Representatives with responses to regulatory questions from customers, related to
products and raw materials.
Regulatory Affairs Manager
Cosmetic Technologies Newbury Park, CA
March 2015 to November 2016
Maintained as required.facility and product registrations (FDA, CA OTC and
Cosmetic, CA Organic).
Develop and maintain Regulatory/technical documentation for new/existing products to meet regulatory and customer
needs.
Create finished good/product MSDS
Assist with product clearances, including coordinating safety (e.g. RIPT, micro challenge) and efficacy tests (e.g. SPF)
with external/internal test. Assist laboratories, and submitting documentation for safety assessments as appropriate
(e.g. customer formulas for European distribution.)
Ensure required/voluntary registrations are completed for products
Provide Marketing and customer regulatory support to extend products into new markets.
Provide Marketing with regulatory support in developing product profiles (e.g. ensuring claims are appropriate for
cosmetics, and can be supported by formula).
Ensure that safety/regulatory requirements are met for products prior to launch.
Review artwork for finished goods.
Issue and maintain technical/regulatory documentation and files.
Implement and document changes on the Basic Change Log and ECNs related to raw materials and formulas.
Provide Marketing/Accounts Representatives with responses to regulatory questions from customers, related to
products and raw materials.
Regulatory Specialist II
Thibiant International Chatsworth, CA
July 2007 to February 2015
Process Certificate of Free Sales, and submit documents for Apostille stamping.
Create and issue quantitative formulas, ingredient lists, finished good MSDS,
BSE/TSE Statements.
Maintain and keep up to date an internal raw material library of technical documents consisting of MSDS, Specifications,
Certificate of Analysis, BSE/TSE,
Non-GMO, and many other regulatory documents.
Create individual raw material profiles (INCI name, percent composition, impurities, and etc.) within the company's
electronic database to help the R&D
Chemists to create new formulas.
Support global customers by providing them the necessary documents to facilitate international product registrations.
Review formulas for proposition 65, CIR, EU Directive, Canada Hotlist, and customer restriction compliance.
Submit product for safety testing, and review study results of SPF
Determination, Critical Wavelength,RIPT, PET, and Ocular.
Regulatory Specialist II
Thibiant International Chatsworth, CA
July 2007 to February 2015
Process Certificate of Free Sales, and submit documents for Apostille stamping.
Create and issue quantitative formulas, ingredient lists, finished good MSDS,
BSE/TSE Statements.
Maintain and keep up to date an internal raw material library of technical documents consisting of MSDS, Specifications,
Certificate of Analysis, BSE/TSE,
Non-GMO, and many other regulatory documents.
Create individual raw material profiles (INCI name, percent composition, impurities, and etc.) within the company's
electronic database to help the R&D
Chemists to create new formulas.
Support global customers by providing them the necessary documents to facilitate international product registrations.
Review formulas for proposition 65, CIR, EU Directive, Canada Hotlist, and customer restriction compliance.
Submit product for safety testing, and review study results of SPF
Determination, Critical Wavelength,RIPT, PET, and Ocular.
Education
Los Angeles Community College
January 2014 to December 2014
Skills
Microsoft Access Quality assurance Organizational skills Supervising experience Excellent
computer skills with proficiency in MS Word, Excel and Outlook. Leadership Chemistry, manufacturing
& controls Project management Writing skills Continuous improvement Driving Microsoft
Outlook GMP Adobe Acrobat Filing Time management Data analysis skills Product
lifecycle management Analysis skills Microsoft Word Product management Technical writing
Communication skills Management
Languages
Bilingual
Additional Information
Authorized to work in the US for any employer
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