Namrata More

Results-driven Regulatory Affairs Professional with 4 years of experience at Colgate-Palmolive, rising from Trainee to Associate. Specialized in global compliance, formulation reviews, and regional reporting for Personal, Oral, and Home Care portfolios. Expertise spans North American frameworks (US MoCRA, Health Canada, Chemical reporting) and international FDA market clearances, including managing complex payment workflows.

Adept at data validation and cross-functional project management, Eager to bring proven multinational compliance expertise to the European cosmetics industry.

Regulatory Affairs Associate – North America Region (Personal Care, Oral Care and Home Care) - Colgate-Palmolive Company - Mumbai, India

(2025-02)

• MoCRA Strategy & Execution: Spearhead critical compliance operations under the Modernization of Cosmetics Regulation Act (MoCRA), driving product listings, cosmetic establishment registrations, amendments, and renewals for the US market.
• Cosmetics Compliance: Manage Cosmetic Product Notifications to Health Canada (CNF) covering new launches, formulation amendments, and product discontinuations.
• California Chemical & Kid's Reporting: Author, track, and submit specialized regulatory filings including California Safe Cosmetic Reporting, and Chemicals for Children's products reporting across multiple states (OR, VT, ME, WA, NY).
• Home Care Compliance: EPA & Chemical Compliance: Execute TSCA Chemical Data Reporting (CDR) cycles and manage annual EPA Maintenance Fee assessments and Annual Establishment Reports.
• Home Care Compliance: State Registrations & Filings: Oversee California Mill quarterly payments, Minnesota yearly Gross Sales Reporting, and biennial Texas Hazardous Consumer Products Registration Renewals.
• Home Care Compliance: Ingredient Safety Reviews: Conduct HC Ingredient Glossary reviews to ensure state compliance, proactively flagging ingredients of concern for further risk assessment.
• International Documentation Management: Orchestrate the issuance of essential export credentials, including Powers of Attorney, Letters of Authorization, and Certificates of Free Sale.
• Process Simplification and Documentation: Manage internal Work Instructions and KPI reporting to optimize throughput. Revised Standard Operating Procedures to clarify cross-functional roles and ensure alignment.

Regulatory Affairs Executive & Trainee – Global Regions (NA, AED, APAC) - Colgate-Palmolive Company - Mumbai, India

(2022-06 - 2025-02)

• US & Canada Registrations: Led Drug Establishment Registrations and Renewals for flagship portfolios (Colgate, Tom's of Maine, Mission Hills); managed FDA Voluntary Cosmetic Registration Program (VCRP) actions and Natural Health Product (NHP) License Notification and Amendment submissions.
• Ingredient List Reviews: Conducted meticulous IL (Ingredient List) reviews for Oral, Home, and Personal Care Products.
• AED Region Operations (Turkey, Israel, Jordan & GCC): Authored technical formulation statements required for commercial clearance and regulatory cross-border dossiers.
• APAC Market Compliance: Coordinated Safety Data Sheets (SDS) review requests and tracker maintenance for Australia and New Zealand, drafted NZ Hazard Notification Letters, and reviewed AICIS documentation for fragrance/flavor compliance.
• Indian Market Upkeep: Maintained compliance license trackers across all active manufacturing plants and managed regulatory fee payment workflows.

Quality Control / Manufacturing Intern - Group Pharmaceutical Ltd. - Malur, Karnataka, India

(2019-06 - 2019-08)

• Gained foundational, hands-on experience in pharmaceutical manufacturing practices, sampling methodologies, and QC laboratory operations for finished formulations.

Post Graduate Diploma - Drug Regulatory Affairs (API & Formulation) - Institute of Pharmaceutical Management, India (2022)

Master of Science (M.Sc.) - Bioanalytical Sciences - G.N.

Khalsa

College, Matunga, Mumbai, India (2020)

Bachelor of Science (B.Sc.) - Biotechnology - B.N.

Bandodkar

College, Thane, India (2018)