Senior Regulatory Specialist – Cosmetics (NA & EU Markets)

Locations

: Bangalore, Hyderabad, or Pune, India

Department: Regulatory Affairs

Role Overview

We are seeking a highly skilled Cosmetic Regulatory Specialist to lead compliance and lifecycle management for North American (USA & Canada) and European (EU & UK) markets. This role ensures that all formulations, packaging, and marketing claims meet stringent international legal requirements while maintaining the active status of all filings and licenses across individual jurisdictions.

Expanded Key Responsibilities

1. Global Market Filing & License Maintenance

• Active License Management: Monitor and manage the renewal of cosmetic establishment registrations and product listings in individual countries (e.g., FDA MoCRA registrations, Health Canada notifications).
• Notification Portals: Execute and maintain digital filings via the CPNP (EU) and SCPN (UK), ensuring all data remains current with any formulation or branding changes.
• Post-Market Compliance: Oversee the maintenance of Product Information Files (PIF) for every individual SKU, ensuring they are readily available for inspection by national competent authorities.
• Local Representative Coordination: Serve as the primary point of contact for "Responsible Persons (RP)" and local legal entities to ensure business continuity and license validity.

2. Formula & Ingredient Assessment

• Review ingredient lists (INCI) against restricted and prohibited substance lists (EU Annexes, California Prop 65, etc.).
• Collaborate with R&D on early-stage formulations for skincare and wellness supplements to ensure global compliance "by design."
• Coordinate with toxicologists to facilitate Safety Assessments (CPSR) required for individual EU member state compliance.

3. Labeling & Claims Substantiation

• Review primary and secondary packaging artwork for mandatory elements (PAO symbols, allergen declarations, and country-specific language requirements).
• Evaluate marketing claims to ensure they comply with FTC (US), ASA (UK), and individual national advertising standards.

4. Regulatory Strategy & Lifecycle

• Monitor emerging regulatory changes (e.g., PFAS bans, microplastic restrictions, IFRA standards) and update existing country filings accordingly.
• Support international expansion by creating modular localization playbooks for regulatory dossiers.

Required Qualifications & Experience

Education

Master’s degree in Pharmacy (M.Pharm), Cosmetic Technology, Chemistry, or a related Life Sciences field.

Experience

5–8 years of core experience in cosmetic regulatory affairs, specifically focusing on US and EU markets

Technical Knowledge:

Proven track record in maintaining active licenses and product notifications across multiple geographies. Expertise in EU Regulation (EC) No 1223/2009 and US MoCRA. Familiarity with ISO 22716 (Cosmetic GMP).

Soft Skills

: Meticulous record-keeping, strong analytical thinking, and the ability to manage complex renewal timelines.

Preference will be given to candidates with experience in Global Regulatory within a GCC setting