Regulatory Affairs Lead
Regulatory Affairs
Algorithm Pharmaceutical Manufacturers Lebanon
Lebanon
July 2006 Masters in Business Administration Lebanese American University July 1996 B.A. Analytical Chemistry Beirut Arab University Experience Regulatory Affairs Lead April 2010 - Present • Head of regulatory team of new product registration and variations for Pharma and Biotech products of in GCC, Levant and North Africa, Iran, Iraq, dealing with multiple stakeholders to achieve the company growths objectives Main tasks: - Ensures timely compilation of complete files according to relevant market regulations - Conducting price analysis ahead of submission to anticipate the price to be granted and accordingly figuring out the best submission strategy aligned with company core objectives - Timely submits files according to Marketing priorities - Manages the Regulatory team, ensuring recruitment, training, career development and motivation - ISO Management Representative & Internal Auditor for Biologix Corporate System Analyst June 2008 - March 2010 (1 year 10 months) Internal Audit / Processes review and Improvement • Identifies misalignment between processes and systems and between systems and organizational structure and suggests corrective actions • Analyzes business processes and works on their improvement and integration • Conducts internal operational audit to ensure compliance with company’s policies and procedures and improve efficiency and effectiveness of operations • Trainer: ISO 9001-2000 and Auditing for internal auditors (ISO 9001- 2000) • Established Code of ethics and business conduct for the group with its related SOPs Material Control Supervisor Page 2 January 2003 - June 2008 (5 years 6 months) • Managing effectively sub-distributors’ inventory in the MENA markets i.e. avoiding stock outs. • Planning, purchasing and shipping products that are promoted in MENA markets and Iran • Coordinating and harmonizing the regulatory planned timelines together with launching shipments to different markets according to regulatory variations’ approval • Ensuring timely shipments to different distributors by planning all the logistics ahead of time (import license, workable LC conditions….) • Establishing, implementing and monitoring purchasing/sales Forecasts • High expertise managing letter of credits • Trainer on managing letter of credits • Management representative for ISO 9001-2000 • Conducts ISO 9001-2000 internal audits • Marketing Services Coordinator January 2001 - January 2003 (2 years 1 month) • Following on agreements between Algorithm, Distributors and Suppliers • Organizing congresses and conferences for Doctors. • Conducting Market Survey to study the acceptability of Biologix (Logistics Center in Dubai Free Zone) in the MENA markets • Active member in Business Development team, identifying potential break through products to replenish the pipeline • Initiating contact with potential Partners Education Lebanese American University Master of Business Administration (MBA), LLM, 2003 - 2006 BAU Bachelor's degree, Analytical Chemistry, 1994 - 1997 Lebanese American University Master of Laws (LLM), Analytical Chemistry, 2015
Analytical Chemistry, Pharma, Gastro