Michel M Email

Michel M Skills

• Cooperation with Stakeholders and partners internally and externally and regulatory support
• Operational Excellence and Timely Delivery
• Global Regulatory Strategy Development and execution
• Regulatory Interactions with FDA, EMA, PMDA and other agencies as the regulatory voice of the company
• Regulatory Strategy
• Business Development
• Product R&D
• Manufacturing Operations Management
• Pharmaceutical Manufacturing
• Cross-functional Alignment
• Recalls
• Responsible Sourcing
• Quality Management
• Quality Auditing
• Personal Drive
• Green Loan Principles (GLP)
• Enterprise Risk
• International Health
• Academic Research
• Solution Delivery
• Drug Development
• International Business
• Validation (Drug Manufacture)
• U.S. Pharmacopeia (USP)
• Biopharmaceuticals
• Employee Engagement
• Pharmaceutical Industry
• Regulatory Affairs
• Regulatory Submissions
• Clinical Trials
• Program Management
• Pharmaceutics
• Regulatory Requirements
• Clinical Development
• Technology Transfer
• Pharmaceutical Sales
• Molecular Biology
• Pharmacovigilance
• Global R&D
• Governmental relations
• Global Management
• Global Health
• Global Business Development
• Global Leadership
• GCP
• IND
• Pharmacokinetics
• Formulation
• SOP
• Biotechnology
• Life Sciences
• FDA
• GMP
• Standard Operating Procedure (SOP)
• Good Clinical Practice (GCP)
• U.S. Food and Drug Administration (FDA)