Ibrahim Harb

Senior Director, Regulatory, Clinical and Scientific Affairs

About

23 years experience in pharmaceutical industry (regulatory and commercial) Global Regulatory Leader for gastro and Women health Hormones Franchise. Extensive knowledge of regulatory affairs environment in multiple regions worldwide (US, EU, Asia, Africa, Middle East) Specialty in drug development and registration in Emerging Markets (Russia, India, China and CIS countries) Experienc with IND and NDA submissions in US, EU ( national and central submission) Filing phase II and III studies for new submission and new indications Managing post marketing activities and life cycle management for the marketed products. 17 years of management experience and 13 years of regulatory supervisory experience Fluent in Arabic and English

Country

United States

City

Vernon Hills

Industry

Pharmaceuticals

Skill

Regulatory Strategy, Regulatory Affairs, Clinical Trials, Pharmaceuticals, Regulatory Requirements, Registration, Regulatory Submissions, IND, Mergers, Cross-functional Team Leadership, Pharmaceutical Industry, Strategy, Pharmaceutics, Sop, Medical Devices, Sales Effectiveness, Pharmaceutical Sales

Experience

Senior Director, Regulatory, Clinical and Scientific Affairs

Abbott - Rapid Diagnostics

2022-7 - Present · 4 yrs 3 mos

Chicago, Illinois, United States

Director of Regulatory Affairs

Abbott Laboratories

2016-5 - 2022-7 · 6 yrs 3 mos

Chicago, Illinois, United States

Associate Director Regulatory Affairs

Abbott

2008-12 - 2022-1 · 13 yrs 2 mos

EPD - Abbott - Chicago

• As the Global Regulatory Leader for SAMe, responsible for developing the regulatory plans for product and/or geographic groups assigned and ensure they are aligned with the commercial business needs, • Serve as the Emerging Market Area regulatory liaison to Commercial Brand Teams. • Reviews regulatory data packages for clinical trial and NDA submissions prior to filing and during the approval process, • Ensure that agreed regulatory strategies are efficiently implemented, and that strategies are maintained in line with changing regulatory and business needs, • Develop and implements internal and external strategies to proactively influence legislation/guidelines with impact on Abbott business, • Lead and manage global regulatory subteam meetings on a monthly basis. • Supervise the work assignments and complete performance management activities related to direct reports.