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A leading pharmaceutical distribution company in the UAE is seeking a Regulatory Affairs Manager to oversee and manage all regulatory activities related to the importation and local distribution of pharmaceutical products. This is an opportunity to join a dynamic and growth-oriented team that is committed to compliance, quality, and patient safety.
· Lead and manage the registration, variation, and renewal of pharmaceutical products with MOHAP, DHA, and DOH.
· Prepare and submit import permit applications, oversee regulatory documentation for product clearance, and monitor compliance with UAE drug laws.
· Maintain valid regulatory licenses for the distribution facility and ensure up-to-date product dossiers and records.
· Represent the company during regulatory inspections and audits and coordinate all responses to authority inquiries.
· Monitor regulatory changes and guidelines, ensuring timely implementation of new requirements.
· Review product labeling, packaging, and promotional materials for regulatory compliance.
· Collaborate with the Quality Assurance team to align on regulatory standards.
· Provide internal training on regulatory protocols and compliance updates.