Regulatory Affairs Specialist

**Regulatory Affairs Specialist

**

**Position Summary

**

The Regulatory Affairs Specialist ensures global compliance of all cosmetic and OTC (Over-the-Counter) products with applicable regulatory requirements. This position supports and manages regulatory activities across product development, manufacturing, labeling, and market expansion. Working cross-functionally with R&D, Quality, Marketing, and Operations, the Specialist maintains the regulatory integrity of new and existing products while proactively monitoring evolving regulations in the U.S., Canada, EU, and other key markets.

This role helps establish and implement the processes, systems, and documentation necessary to maintain a compliant and robust global regulatory framework.

**Key Responsibilities

**

**Regulatory Documentation & Product Compliance

**

• Prepare and maintain INCI ingredient lists, quantitative formulas, Component Composition Summaries (CCS), Safety Data Sheets (SDS), and claims substantiation packages.

• Ensure all technical documentation, product registrations, and label claims are accurate and compliant with global regulatory frameworks.

• Manage and maintain regulatory databases, dossiers, and master files to support audits and inspections.

**Labeling & Claims Review

**

• Review product labeling, artwork, and marketing materials for compliance with FDA, MoCRA, Health Canada, EU Cosmetics Regulation (EC) No 1223/2009, and state-level requirements such as California Proposition 65.

• Partner with Marketing and Legal to ensure that all consumer-facing communications meet substantiation and compliance standards.

**Regulatory Submissions & Market Expansion

**

• Support or manage product listings and facility registrations under FDA MoCRA.

• Prepare and submit EU CPNP/SCPN notifications, safety assessments, and global market dossiers as required.

• Coordinate with international partners to ensure timely completion of product registrations and renewals.

**Regulatory Intelligence & Training

**

• Monitor, interpret, and communicate changes in global regulatory requirements affecting product composition, labeling, and claims.

• Update R&D formulation guidelines and internal SOPs to reflect current regulations.

• Deliver regulatory training and guidance to cross-functional teams as appropriate.

**Cross-Functional Collaboration

**

• Provide regulatory input during New Product Development (NPD) to ensure early-stage compliance.

• Work closely with R&D and Quality on raw material reviews, supplier documentation, and formulation change control.

• Participate in audits, legal inquiries, and product defense initiatives as needed.

**Qualifications

**

• Bachelor’s degree in Chemistry, Biology, Regulatory Science, or related scientific discipline.

• **2–4 years of experience

  ** in Regulatory Affairs for cosmetics, OTC, or related personal-care categories.

• Strong working knowledge of FDA, MoCRA, Health Canada, EU Cosmetics, and state-specific regulations.

• Experience in SDS authoring, label and claims review, and global product registration.

• Understanding of Good Manufacturing Practices (cGMPs) and quality documentation.

• Familiarity with NGO and retailer compliance frameworks (e.g., Non-GMO Project, Target Clean, Ulta Clean).

• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Access); experience with regulatory systems (WERCS, Veeva Vault, SAP EHS, or equivalent) preferred.

• Strong analytical, organizational, and written communication skills.

• Ability to interpret regulations, resolve complex compliance questions, and collaborate effectively across teams.

**Core Competencies

**

• **Regulatory Insight:

  ** Deep understanding of product classification and global regulatory frameworks.

• **Attention to Detail:

  ** Ensures accuracy and consistency in documentation and submissions.

• **Cross-Functional Communication:

  ** Translates regulatory requirements into actionable guidance for R&D and Marketing teams.

• **Problem Solving:

  ** Identifies potential compliance risks and develops timely solutions.

• **Adaptability:

  ** Keeps pace with evolving legislation and regulatory expectations.

**Performance Indicators

**

• Timely and accurate completion of product registrations and listings.

• Zero compliance-related product holds or audit findings.

• Up-to-date regulatory documentation and training for all assigned product lines.

• Consistent support of new product launches within designated timelines.