Ahmed Allabidy

Senior Manager, Clinical Label Design & Management, Global Clinical Drug Supply @Alexion Pharmaceuticals, Inc.

Boston, MA, US

Manages all aspects and end-to-end process of clinical labeling authoring and design/creation (new & revised - booklets & single panel labels), regulatory submissions, negotiations, addressing comments, approvals & artwork printout ensuring accuracy, quality & on time delivery to support all clinical trials. Leading member in Alexion & AstraZeneca’s inspection & testing team for the quality and regulatory label management system (Prysim360/Loftware) planned to go live in Q1 2025. Manages Alexion AstraZeneca’s clinical label management system (LRA SmartSupplies) for label content design and creation phrase generation, translation, review, and approval, to addressing requested regulatory label changes and comments during submission & obtaining approval on a timely manner. Ensures cross-functional teams driving, partnership and collaboration with CSMs,(GCO), Medical Affairs & QA to evaluate and understand the preliminary design of the study and develop an appropriate label strategy. Decides the study appropriate kit design & provide support for IND filings as required. Ensures continuous improvement of the label workflow & manages the clinical label SOPs updates and revisions, creates the label work instructions and procedures and guidelines for clinical trial material and labeling prescriptions, characteristics & content (FDA USPI and EU SmPC) and ensure GxP compliance, US and EU product labeling requirements, regulations, and guidelines. Vendor Management: Customer focused and primary accountable liaison with clinical label external regulatory and translation vendors. Complete quarterly business and performance metrics. Negotiate label quotes and work orders for new trials. Alexion & AstraZeneca’s labeling subject matter expert (SME) in regulatory and health authority audits & inspections. Proactively address risk management issues and appropriately escalates to leadership and proposes risk mitigation strategies.

Cairo University

Rotational Internship Rounds in Dentistry

October 6 University

Bachelor's Degree (BDS), Dental Medicine & Oral Surgery

Cairo University

Masters of Dental Surgery (MDS), Oral/Maxillofacial Surgery

English High School

High School

Saint George's School

Elementary & Middle School