Director
Cigalah Group
مجموع سنوات الخبرة :11 years, 10 أشهر
Regulatory affairs Director from March 2014, in service WITH:
Cigalah Group.
Group of companies ( Pharmaceutical Division, and Medical Devices Division)
Sole Distributors for several World Class International Innovative and Generic companies from across the Globe,
Reference Companies associated with:
30 different multinational companies, including Merck Serono (Italy, Swiss), Boehringer
Ingelheim (Germany, France), Actelion pharmaceutical LTD (Swiss), Nycomed (Germany),
Reckitt Benckiser (UK, USA), Amgen (USA, Netherlands), Bayer Consumer care AG
(Swiss), Allergan (Ireland, USA), Biotest AG (Germany), Nutricia (Netherland, UK), Liptis
(USA), 3M ESPE (Germany), Schwars pharma AG (Germany), Forest Tosara (Ireland),
Gabriel Health LTD (Greec), Inqpharm (Germany), LG (Korea), Pharmacosmos (Denmark),
Church and Dwisht (Canada), Alkopharm (France), Pharmachemie BV (Netherland),
Medac GMBH (Germany), Unilabs Management & Servies SA (Swiss), Bethco (USA),
Dr.Reddy's Company (India), Serum Institute (India), Claris Life science LTD (India),
Wockhardt (India), Cairo Company (Egypt), Eva pharma (Egypt), Memphis (Egypt) and
Mepaco (Egypt)
Duties and Responsibilities:
• Preparation and submission of NeeS Dossiers, for registration of Marketing
Authorizations Applications with SFDA and GCC.
• Preparation and submission of company Master files for Company registrations with
SFDA and GCC.
• Apply and seek approvals from monitoring agencies like SFDA and GCC for various
minor product variations applicable.
• Follow up activities with SFDA and GCC during registration process and subsequent
replies to institutional queries thereupon.
• Submission and follow ups with QCL for product analysis and results, for product
registration.
• Arrange GMP inspections of companies and production lines for registration.
• Regulatory meetings and counseling with companies and clients.
• Established the medical devices sector in Cigalah Group.
• Getting of many Medical Devices MDNR Numbers through MDNR system at SFDA.
• Getting of many Authorised Representative Lisence (AR)
• Very well dealing with the All Medical Devices systems like, MDNR, MDEL, MDMA, etc.
Professionalism:
Continuous Pharmacy Education
SFDA, AND SAUDI COUNCIL.
Dr. Hajed Hashan
Executive Director of Licenses.
Food and drug authority, KSA.
Dr. Mohammed Al Haidary,
Head of the Registration Department,
G.C.C Office, Riyadh K.S.A
Dr. Hamad Turki Al-Enazi
Head of Clearance Department, SFDA
Drug Regulatory Affairs Department As Regulatory affairs Manager, From 2003.
Regulatory affairs Director from March 2014
• Certificate of Thanks and Appreciations from WHO. • Certificate of preparing NeeS files from Mesned Center for Pharmaceutical Consulting. Presentations made at college: Diabetes Mellitus, Pencillinase Resistant Pencillins, Congestive Heart Failure, Principle of Chemotherapy, Third Generation Cephalosporins (Cefexime),
Summary of Educational & Technical Attainments: • Bachelors Degree in Pharmacy, year 2003, King Saud University, Riyadh, K.S.A.