Regulatory Associate - International Regulatory Affairs

Overview

The Regulatory Associate will support global compliance and intelligence efforts for the company's portfolio of herbal wellness, food supplements, and cosmetic products. Stationed in Dubai, this role ensures ingredient and product formulation compliance across international markets while regularly updating the organization on regulatory changes that may affect product strategies and operations.

Primary Responsibilities

• Evaluate the regulatory status of herbs, botanicals, excipients, and other ingredients across key regions including the US, EU, APAC, and GCC to ensure adherence to local laws.
• Monitor global safety alerts, market recalls, and regulatory updates relevant to herbal medicines, food supplements, and cosmetics.
• Provide expert regulatory input for product registrations, renewals, and product claims worldwide.
• Support internal teams by applying standards from authorities such as FDA, EMA, TGA, SFDA, ESMA, and ASEAN.
• Continuously monitor emerging regulations and guidance documents from global markets and frameworks, including but not limited to EU Cosmetic Regulation EC 1223/2009, FDA DSHEA, ASEAN Cosmetic Directive, and GCC regulations.
• Engage with trade associations and external partners, like AHPA, IADSA, and Cosmetics Europe, to stay ahead of regulatory developments and harmonization efforts.
• Maintain a Regulatory Intelligence Tracker and periodically distribute briefs highlighting safety alerts, regulatory catalog updates, ingredient limits, and banned substances.
• Facilitate communication within formulation, R&D, and marketing to ensure prompt reaction to regulatory changes.
• Manage a Regulatory Alerts and Compliance Database documenting global compliance data, safety notices, and ingredient restrictions; ensure timely communication and response.
• Review and authorize ingredient usage in new or reformulated products in coordination with formulation and phytochemistry teams.
• Develop, maintain, and enhance the Regulatory Ingredient Database (RID), particularly involving supplements, to include comprehensive ingredient information and regional compliance data.
• Coordinate with IT for improvements of regulatory data systems and prepare quarterly updates on relevant regulatory changes impacting formulations.
• Maintain robust documentation practices to ensure audit readiness and clear traceability of regulatory decisions and communications.

Qualification & Experience

• Bachelor's or Master's degree in Pharmacy or Pharmaceutical Sciences.
• At least 3 years of experience in regulatory affairs within pharmaceutical, herbal, nutraceutical, or cosmetic industries.
• Thorough working knowledge of multiple international regulatory frameworks such as FDA DSHEA, EU Cosmetic Regulation, ASEAN Cosmetics Directive, and GCC standards.
• Experience or familiarity with regulatory database management and ingredient classification is advantageous.

Core Competencies

• Strong analytical and investigative capabilities with meticulous attention to detail.
• Excellent communication, documentation, and presentation skills.
• Proficient with regulatory intelligence platforms, database management tools, and Microsoft Office including SharePoint.
• Ability to interpret complex regulations and convey practical guidance effectively.
• Self-motivated, well-organized, and capable of multitasking across diverse global projects simultaneously.