Regulatory Affairs Specialist

Join to apply for the Regulatory Affairs Specialist role at SIGAN AMERICA, LLC.

$20.00/hr - $25.00/hr

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.

• 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.

• 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.

• 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.

• 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.

• Mid-Senior level

• Full-time

• Legal

• Wellness and Fitness Services