I. Current Job : Standardization Manager-at JPI Web site: [ www.jpi.com.sa ]- Location: KSA/ RIYADH/ Pharmaceutical Industries.-Member of HIKMA Pharmaceuticals PLC [ Web site: www.hikma.com ]--DUTIES AND RESPONSIBILITIES;---------------------------------------------------- Initiate/ Maintain all issues related to the formulas of products in coordination with QA/ QC/ R&D / Marketing / planning /procurements department(s).-- Initiate/ Maintain all issues related to the routing of manufacturing process in coordination with QA/R&D/ Marketing / planning /procurements department(s).-- Initiate/ update all work centers in coordination with all department(s).-- Generate / update scrap factor(s) for all materials used in manufacturing.-- Handling all issues related to new / update all pharmaceutical packaging materials in co-ordination with all departments/ in addition to arrange vender(s) qualification(s) inside KSA & overseas.-- Initiate and verifying all Pharmaceutical packaging materials issues -and arrange necessary to raise up our customer acquisition/ satisfaction and retention.-- Handling all necessary procedures; for Manufacturing started from purchasing of goods & assure availability / in accordance with marketing / sales / planning & supply chain department(s).-- Initiate/ handling monitor all pharmaceutical issues related for qualities in co-ordination with other department(s) using international standards SOP(s) & guidelines/ which will facilitate our day/day practices.

JOB DESCRIPTION;--Our JOB duties part of Marketing department;Standardization Dept:--* Handle executive business plan for any upcoming pharmaceutical products ( Including Products Promotion & launching campaign).--* Handling 75% for whole necessary procedures necessary; for Manufacturing started from purchasing of goods & assure availability / in accordance with marketing / sales / planning & supply chain dept.--* Responsible with all Pharmaceutical packaging materials issues which will lead to raise up customer acquisition/ satisfaction and retention.--* Responsible & dealing to raise up qualities/ International standards matching with strategic enterprise guidlines.--* Responsible for all international pharmaceutical regulatory affairs. as well as domestic/ in co-ordination of marketing department.--Regulatory Affairs Dept :-* Responsible for all international pharmaceutical regulatory affairs. as well as domestic.-* Responsible & dealing to raise up qualities/ International standards matching with strategic enterprise guidlines.-* Monitoring & reviewing CTD to be ready for submssion-* Responsible with all Pharmaceutical packaging materials issues which will lead to raise up customer acquisition/ satisfaction and retention.-* Responsible to handle all requirements requested through SFDA.

DUTIES AND RESPONSIBILITIES;----------------------------------------------------II. Regulatory Affairs Management ( International + Domestic affairs ) :-Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. -Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. -Maintain current knowledge of relevant regulations/ including proposed and final rules. -Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. -Monitoring documentation efforts to ensure compliance with domestic and international regulations and standards.-Provide responses to regulatory agencies regarding product information or issues. -Review all regulatory agency submission materials to ensure timeliness/ accuracy/ comprehensiveness/ or compliance with regulatory standards. -Develop and maintain standard operating procedures (SOPs) or local working practices. -Develop regulatory strategies and implementation plans for the preparation and submission of new products. -Direct the preparation and submission of regulatory agency applications/ reports/ or correspondence. -Establish regulatory priorities or budgets and allocate resources and workloads. -Provide regulatory guidance to departments or development project teams regarding design/ development/ evaluation/ or marketing of products. -Contribute to the development or implementation of business unit strategic and operating which coming from HIKMA plans. -Manage activities such as audits/ regulatory agency inspections/ or product recalls. -Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats. -Googling & review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. -Train staff in regulatory policies or procedures- through continous llearning programm.-Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations. -Participate in the development or implementation of clinical trial protocols - once request.-Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. -Communicate with all internal discoveries and depositions with legal Hikma department staff/ regarding patency ....etc

II. Teacher Assistance: -Al-albayt International University - JORDAN- Web site: ( www.aabu.edu.jo )-Location: Mafraq - Jordan -Company Industry: Education. -Work Experience : January 1994 - April 1998 --DUTIES AND RESPONSIBILITIES;---------------------------------------------------Handle all teaching issues & preparing all training materials related for laboratories teaching / undergraduate level courses.- Biology Section/Science faculty.-Develop teaching materials such as teaching approach summary/ visual aids/ answer keys/ supplementary notes/ and any other possible assistance.-Monitoring all lab technicians subordinates to assure full lab. preparation(s) & all necessary issues related for. ( Including Teaching students materials/ laboratories equipments & all necessary studying material(s) related issues.-Provide instructors with assistance in the use of audiovisual equipment necessary for teaching.-Demonstrate use of laboratory equipment/ and enforce laboratory rules.-Inform students of the procedures for completing and submitting class work such as lab reports.-Evaluate and grade examinations/ assignments/ and papers/ and record grades.