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Over mij
Pharmaceutical Regulatory Affairs Professional with 10+ years of experience in CTD/eCTD dossier preparation, regulatory submissions, query response management, product registration, and lifecycle maintenance for global markets. Skilled in dossier compilation, gap analysis, variation and renewal applications, technical justifications, labeling review, and regulatory compliance. Experienced in supporting registrations across Africa, Asia, and emerging markets. Committed to delivering accurate, high-quality, and compliant regulatory documentation within agreed timelines.... Lees meer