Executive Search Firm Monroe Consulting Group is recruiting a Senior Regulatory Affairs Specialist on behalf of a leading pharmaceutical distribution and supplier company. The role is responsible for managing regulatory submissions and dossier

preparation for pharmaceutical and food supplement products and ensure compliance with Philippine FDA and country-specific regulatory requirements.

Key Responsibilities

• Manage the preparation and submission of FDA applications for product registration, renewal, variation, and other regulatory transactions for pharmaceutical and food supplement products.

• Ensure compliance with FDA and international regulatory requirements by monitoring, evaluating, and implementing updated regulations, guidelines, and circulars.

• Coordinate with regulatory authorities, foreign manufacturers, and cross-functional departments regarding regulatory submissions, product compliance, and documentation requ...