Gastroenterology
Global

Gastroenterology Experts

Hanna El Mouallem

Regulatory Affairs Specialist
Regulatory Affairs
Algorithm Pharmaceutical Manufacturers Lebanon
Lebanon

Biography

Regulatory Affairs Specialist at Algorithm Pharmaceutical Manufacturers January 2016 - Present Algorithm/Biologix provide regulatory support and guidance to many multinational companies, such as Shire, Biogen, Amarin, Horizon, Sigma-Tau, Acino... to ensure that registrations, renewals and variations are done in compliance with the applicable regulations in the MENA region, by: - Planning and establishing challenging timelines for registration submission. - Reviewing and assessing core dossiers. - Preparing and submitting registrations, variations and renewal files. - Liaising with sub-distributors in all the MENA markets to ensure timely submission and approval. - Coordinating with the multinational companies on a regular basis by holding bi-weekly teleconferences. - Updating continuously all stakeholders on the most recent guidelines and circulars and interpreting their potential impact on the business. - Arranging several business trips to train medical experts on the latest regulatory trends in the region or to ensure fruitful negotiations with health authorities. - Providing guidance on the optimal regulatory strategy to follow, while coordinating with pricing committee, medical affairs, marketing and logistic departments. - Managing regulatory surveys for all the MENA markets. - Organizing and updating the regulatory archive and database. Intern at Hôtel-Dieu de France October 2014 - May 2015 (8 months) Intern at Laboratoire Dr. Chelala July 2014 - September 2014 (3 months) Intern at Université Saint-Joseph de Beyrouth June 2014 - July 2014 (2 months) Internship for Masters in Pharmacology Students. Intern at Université Saint-Joseph de Beyrouth June 2011 - July 2011 (2 months) Page 2 Pharmaceutical compounding, creating particular pharmaceutical products to fit the unique need of a patient, by combining or processing appropriate ingredients using various tools, for medically necessary reasons. Education Université Saint-Joseph de Beyrouth Doctor of Pharmacy (PharmD), Pharmacy, 2010 - 2015 Université Saint-Joseph de Beyrouth Master’s Degree, Pharmacology, 2014 - 2014 Georgetown University Certificate of English Proficiency, 2013 - 2013 Collège des Soeurs des Saints-Coeurs SSCC Kfarhbab High School, 1995 - 2010 University of Cambridge Certificate in Advanced English CAE, 2009 - 2009 Lebanese American University Model United Nations, Representing the USA in the Security Council, 2008 - 2008 University of Cambridge First Certificate in English FCE, 2008 - 2008 University of Cambridge Preliminary English Certificate PET, 2007 - 2007 Honors and Awards Thesis Viva: Very Honorable, with Committee Praise, Class Valedictorian Award, Class Valedictorian Award,  

Research Interest

 Pharma, Market

Global Experts from Lebanon

Global Experts in Subject

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