Regulatory Affairs Associate

• Manage all regulatory submissions to MoH, DDF, and NHPQC for new registrations, renewals, variations, and product lifecycle maintenance.
• Coordinate registration and renewal activities for pharmaceutical and healthcare products from EU, India, Pakistan and other approved manufacturers.
• Prepare, review, and submit registration dossiers in compliance with Cambodian regulatory requirements.
• Follow up on submitted applications until approval is obtained.
• Manage product labeling updates, packaging changes, company name changes, and other regulatory variations.
• Prepare and coordinate package insert translations in accordance with regulatory requirements.
• Ensure timely renewal of company, warehouse, and other regulatory licenses.
• Obtain import permits from MoH and coordinate with Health Authorities for shipment clearance.
• Support marketing activities by obtaining approvals for promotional materials, social media content, round table meetings, and other promotional events.
• Coordinate with regional and global Regulatory Affairs teams to ensure timely submission of high-quality applications.
• Provide regular regulatory status reports, milestone updates, and compliance reports to management.
• Build and maintain strong regulatory networks with relevant authorities and stakeholders.
• Perform other duties assigned by management.

Quality Assurance (QA)

• Develop, review, implement, and maintain SOPs, guidelines, and quality documents.
• Ensure all SOPs and quality documents are updated and aligned with current practices and regulatory requirements.
• Conduct SOP and quality-related training for relevant departments.
• Perform self-inspections and internal audits, particularly in warehouse operations, to ensure compliance with SOPs and guidelines.
• Monitor and enforce adherence to quality systems, procedures, and regulatory requirements.
• Investigate quality issues, deviations, and non-conformities, and implement corrective and preventive actions (CAPA).
• Maintain quality records and documentation in compliance with company and regulatory requirements.