Salem Mostafa Salem Abu Khaizaran

Biography

leads regulatory science directorate through preparation, filing ANDA and liaison and negotiation with Competent Authorities (CAs) on matters related to drug development issues and Labeling development and Regulatory input in drug development, Submissions and Variations, Line extensions and Renewals and All communications and negotiations with CAs related to registration and maintenance of registrations and labeling preparation, Regulatory Compliance (Labeling compliance, Product compliance) All regulatory obligations related to recalls, withdrawals and complaints, Regulatory representation to trade association, Interactions with CAs on horizontal regulatory matters and Survey and interpretation of legislation evolution. leads regulatory science directorate through preparation, filing ANDA and liaison and negotiation with Competent Authorities (CAs) on matters related to drug development issues and Labeling development and Regulatory input in drug development, Submissions and Variations, Line extensions and Renewals and All communications and negotiations with CAs related to registration and maintenance of registrations and labeling preparation, Regulatory Compliance (Labeling compliance, Product compliance) All regulatory obligations related to recalls, withdrawals and complaints, Regulatory representation to trade association, Interactions with CAs on horizontal regulatory matters and Survey and interpretation of legislation evolution.

Research Interest

pharmaceutical industry