Manager Regulatory Affairs
Merck Sharp & Dohme
Total des années d'expérience :10 years, 3 Mois
Responsible for registration processes with Saudi FDA
Responsible for complete registration processes for pharmaceutical products in GCC.
• 1/2006 - till now as Assistant Manager Regulatory Affairs in Jamjoom Pharmaceuticals Co., Ltd. in Saudi Arabia.
Title: Assistant Manager
Department: Regulatory Affairs Department
Responsibilities as following:
1. Submission of registration files as CTD Format (NeeS) in the following countries:
1) Saudi FDA.
2) Jordan FDA.
3) UAE.
4) South Africa.
5) Kenya.
6) Kuwait.
7) Qatar.
8) Morocco.
9) Oman.
10) Kazakhstan.
11) Bahrain.
12) Algeria.
2. Submission of registration files in different foreign countries as per their guidelines (Egypt, Kazakhstan, Sudan, GCC countries \[, Bahrain & Yemen\], Francophone countries \[Gabon, Mali, Cameroon, Ivory Coast\], Ethiopia, Algeria, Tunisia, Lebanon & Iraq).
3. Responding all the queries coming from the above mentioned ministries of health as per guidelines.
4. Communicating with different departments in Jamjoom Pharmaceuticals Co., Ltd. (QA, QC, AMD, Supply Chain, Warehouse, Artwork Development, Formulation Department, Microbiology Department Validation Department, Marketing and Export Department & Our Representatives in front of authorities) in order to fulfill the different requirements asked by Saudi FDA & other ministries of health as per guidelines.
5. Responsible for Final Approval of Artworks in local market for new products & for export including English, Arabic & French texts from Q.A, Regulatory view of point as per guidelines for each country.
6. Handling the following responsibilities in RA department:
1) Arranging GMPs, US DMF, COS & Declaration letters from different suppliers through the supply chain.
2) Arranging Clinical & non clinical study reports and PSUR through Scientific Department in Jamjoom Pharmaceuticals Co., Ltd.
3) Arranging BE study reports through Scientific Department in Jamjoom Pharmaceuticals Co., Ltd.
4) Arranging the primary & secondary reference standards and HPLC columns through Supply Chain Department.
5) Supervising all regulatory Officers.