Sogol Badakhshan Noori

Kompetens

Regulatory Compliance (FDA, EMA, GMP)
•Training and Development Expertise
•Lean and Business Process Management
•SME Network Development
•Project Management
•Regulatory Document Authoring & Review
•CTD Dossier Preparation & Submission
•Veeva Vault Document Management
•Clinical Trials & Medical Affairs
•Regulatory Process Optimization
•Market Authorization & Product Registration
•Risk Assessment & Pharmacovigilance

Om

Licensed pharmacist with extensive experience in regulatory compliance, process management, learning and development, and pharmaceutical industry operations. Strong expertise in FDA, EMA, and GMP regulations, regulatory documentation, and submission processes. Adept at leading product approvals, managing complex projects and awareness sessions, and ensuring compliance with global regulatory requirements. Proven ability to navigate cross-functional collaborations and drive efficiency in regulatory affairs processes.