Asmaa Abbas Email and Phone Number

Senior regulatory affairs specialist with diversified experience in multinational corporates with more than 4 years experience

Assignment responsibilities:- Individual contributor for the planning , tracking , coordination and execution of products label updates (including safety label changes) in compliance with internal requirements and local regulations - Ensure that all regulatory submissions (New marketing authorization applications, renewals, variations, notifications) are prepared and filed in timely manner for company products.-Follow up all steps for Authorization/approval of these… Show more Assignment responsibilities:- Individual contributor for the planning , tracking , coordination and execution of products label updates (including safety label changes) in compliance with internal requirements and local regulations - Ensure that all regulatory submissions (New marketing authorization applications, renewals, variations, notifications) are prepared and filed in timely manner for company products.-Follow up all steps for Authorization/approval of these submissions.-Gain Regulatory Authority approval for marketing authorizations for new products.-Maintain all existing product marketing authorizations and gain Regulatory authority approval of variations to these authorizations as required.-Manage any further information requests from local Regulatory authority in a timely manner, submission of any subsequent responses/product documentation updates to local Regulatory authority.-Review product information in accordance with legal and regulatory requirements; ensure that all prescribing information is accurate, update and approved by both company and relevant Regulatory authority in accordance with company policies and local regulations.-Responsible for updating the Company's database and systems ­-Represent AbbVie in the relevant pharmaceutical trade associations and liaise with external stakeholder.­-Establish and maintain good relationship with all involved regulatory institutions in Egypt.Coordinate and ensure effectiveness of Regulatory Affairs function Show less

o Stability department (Since February 2011, currently working there)o Drug policy and planning department (July 2009, February 2011)o Cosmetics Inspection department (June 2009, July 2009)Work done :o Reviewing & preparing stability studies especially for imported & Biological drug products.o Reviewing & preparing import approvals for drugs & cosmetic products.o Preparing pharmaceutical raw materials plan for pharmaceutical drug companies.o Reviewing &… Show more o Stability department (Since February 2011, currently working there)o Drug policy and planning department (July 2009, February 2011)o Cosmetics Inspection department (June 2009, July 2009)Work done :o Reviewing & preparing stability studies especially for imported & Biological drug products.o Reviewing & preparing import approvals for drugs & cosmetic products.o Preparing pharmaceutical raw materials plan for pharmaceutical drug companies.o Reviewing & preparing industrial registers & drug factories licenses. Show less

o Stability department (Since February 2011, currently working there)o Drug policy and planning department (July 2009, February 2011)o Cosmetics Inspection department (June 2009, July 2009)Technical work done :o Reviewing & preparing stability studies especially for imported & Biological drug products.o Reviewing & preparing import approvals for drugs & cosmetic products.o Preparing pharmaceutical raw materials plan for pharmaceutical drug companies.o… Show more o Stability department (Since February 2011, currently working there)o Drug policy and planning department (July 2009, February 2011)o Cosmetics Inspection department (June 2009, July 2009)Technical work done :o Reviewing & preparing stability studies especially for imported & Biological drug products.o Reviewing & preparing import approvals for drugs & cosmetic products.o Preparing pharmaceutical raw materials plan for pharmaceutical drug companies.o Reviewing & preparing industrial registers & drug factories licenses. Show less

Pharmacist

o Reviewing & preparing industrial registers & drug factories licenses and evaluating pharmaceutical projects.