Ana Ramirez
Los Angeles,CA
Summary
I am a dynamic and detail-oriented regulatory compliance professional with over 15 years of experience in Regulatory Affairs in the personal care and OTC space. Proven expertise in navigating complex regulatory frameworks including US FDA, EU Cosmetic Regulations, and other international standards. Demonstrated success in ensuring compliance in product formulations and labeling. Adept at working with cross-functional teams, liaising and driving continuous improvement in compliance practices. Systematic and practical with sound judgment, an analytical mindset, and good problem-solving skills.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Sr. Regulatory Specialist
ZO Skin Health, Inc.
Irvine, CA
11.2020 - Current
- Conduct comprehensive assessment of product formulations, ensuring compliance with safety standards domestic and international markets, global ingredient restrictions, and labeling requirements
- Prepare and submit regulatory filings for product registrations and manage ongoing regulatory dossiers across various jurisdictions
- Collaborate with R&D, Product Development and Marketing teams to ensure marketing claims and product labels meet regulatory standards and timelines
- Optimize documentation to achieve registration in all markets, including but not limited to Canada, Australia and EU, within the personal care and OTC drug product categories
- Monitor emerging regulations, ensuring timely adaptation to new legislation
- Maintain communication with manufacturers for all quality documentation
- Serve as the main liaison for over 10 countries and distributors, ensuring timely completion of product registrations
- (EU, LATAM, ASEAN, GCC etc.)
- Compile technical dossier for registration
- Collaborated cross functionally with Marketing, PD and Legal to make sure claims were substantiated and viable for various product types within personal care and OTC drug categories
- EU CPNP, UK, Canada, MoCRA notification filings.
Sr. Regulatory Affairs Specialist
COTY
Calabasas, CA
10.2017 - 10.2020
- Reviewed and approved product formulations, ensuring compliance with relevant regional regulations and ingredient restrictions
- Developed and maintained comprehensive regulatory submissions for global markets, including the EU, Asia, and Latin America
- Collaborated with cross-functional teams to ensure the company's product portfolio complied with both existing and upcoming regulatory changes
- Provide EU Product Information File (PIF) training to new recruits and provide ongoing support as needed
- Evaluate data for acceptability and compliance; including compatibility, stability, claims substantiation, safety, and raw material technical documents
- Act as a bridge between chemists and support functions (Toxicology, Analytical, Product Testing, and Microbiology) to troubleshoot questions/concerns with product PIF requirements
- Communicate with Third Party Manufacturers to obtain the documentation required for Registrations and PIF
- EU CPNP Notification filings for COTY fragrances
- Reviewed and approved ingredient lists
Regulatory Affairs Specialist/Document Control Supervisor
COTY
North Hollywood, CA
09.2013 - 10.2020
- Provide Regulatory & Document Control training to direct reports
- Supervise 2 direct reports
- Register formulas internationally via the Coty registration database directly with distributors
- Create INCI declarations
- INCI and artwork approvals for OPI
- Ensure labeling adheres to regulatory standards
- VCRP, EU CPNP, CDPH, CASB484 and Canada Notification filings
- Provide R&D information and guidance on regulatory and raw material issues
- Aid in the resolution of any registration questions from requesters or authorities
- Liaison with international authorities to provide assistance concerning global product registration
- Formula assessment to ensure global regulatory compliance
- Review all new and alternate raw materials to ensure global compliance
Regulatory Affairs Specialist
OPI Products, Inc.
North Hollywood, CA
10.2008 - 08.2013
- Develop Qualitative & Quantitative Formulations
- Develop Ingredient Declarations, INCI lists for labels
- Liaise with TPMs for all technical documentation needed for product compliance, SDS, COA, BSE, TSE etc
- Reviewed artwork & provided approvals
- Created combination of Ingredient listing for giftsets, promotional items, and packs
- Submit formulation & supporting documentation to Contract Toxicologist for Safety Assessments
- Work with sales teams to manage documents required for product samples for new launches
Document Control Clerk
OPI Products, Inc.
North Hollywood, CA
08.2007 - 10.2008
- Develop Qualitative & Quantitative Formulations
- Request & review all technical documents from TPMs including COA, SDS, raw material composition, TDS, IFRA, Reach compliance, BSE, non-animal testing documents etc
- Create Master Formulas with Trade name and Supplier information
- Create Batch Sheets/ Manufacturing processes for compounding in the factory
- Create Bill of Materials
- Submit new formula information for the creation of Finished Product SDS (Safety Data Sheet)
- Worked with shipping to provide required documentation
- Develop Quantitative & Qualitative Formulas
Education
High School Diploma -
San Fernando High School
Skills
- Global Regulatory Compliance Knowledge
- Labeling & Marketing Claims Review
- Regulatory Submissions
- Cross-functional Collaboration
- Ability to review and comprehend regulatory writings
- Knowledge of 21 CFR 210 and 211 FDA FD&C Act
- Overall knowledge of business processes in Regulatory, R&D, and Quality
- Microsoft Office (Outlook, Word, Excel, PowerPoint)
- International regulations
Certification
- Certificate in Cosmetic Regulatory Essentials, Institute of Personal Care Science, Currently Enrolled
- State of California Notary Public, National Notary Association, 2024
Languages
- English
- Spanish
Timeline
Sr. Regulatory Specialist
ZO Skin Health, Inc.
11.2020 - Current
Sr. Regulatory Affairs Specialist
COTY
10.2017 - 10.2020
Regulatory Affairs Specialist/Document Control Supervisor
COTY
09.2013 - 10.2020
Regulatory Affairs Specialist
OPI Products, Inc.
10.2008 - 08.2013
Document Control Clerk
OPI Products, Inc.
08.2007 - 10.2008
High School Diploma -
San Fernando High School