Regulatory Affairs
Roche
Total years of experience :17 years, 11 Months
Associate Regulatory Affairs September 2012-present
LEO Pharma, Dubai, UAE
Responsible for Qatar, Bahrain, Yemen, Pakistan and Mauritius plus others:
• Ensuring that company's products comply with the regulations of GCC health authorities;
• Provide principals with a list of all regulatory documents required to make submissions;
• Co-ordinate/prepare/review regulatory and documents submissions. Arrange translations of regulatory documents as required;
• Working with regulatory data and software resources;
• Follow up and monitor approvals process with business partners as well as health authorities;
• Make submissions of amendments, updates, annual reports etc. as requested by the management; Support management team on the sourcing strategy. Collaborate with involved departments in teamwork in order to define a regulatory strategy;
• Manage merging activities by supporting the corporate team with advices and local requirements, timelines and process;
• Participate efficiently in analysis and evaluation of business strategies, by giving accurate and proper regulatory solutions to enhance merging and new projects activities;
• Integrate the regulatory activities with network of merging and company strategic activities;
• Effectively participate in company managements meetings, give regulatory overview to different departments, and align regulatory activities with company strategic projects.
• Review and evaluate Regulatory Pricing, give recommendations and take corrective actions when needed to support the company pricing strategy.
• Train new colleagues, and internship graduates by organizing hands on group work on ongoing projects.
• Continuously develop and enhance business relationship with internal and external stakeholders by organizing meetings and workshops, and regular feedback.
• Undertaking and managing regulatory inspections for internal and external audits;
• Carry out SWOT analysis for new guidelines; participate in RWAG meetings to improve the GCC regulatory context within the GCC.
Senior Medical Representative September 2007 - 2012
Duties:
• Resolving customer problems by providing flexible solutions;
• Adhering to the company Codes of Conduct;
• Successful management of key accounts;
• Preparing and following cycle plans to ensure constant and effective communication with stakeholders;
• Executing projects business plan focused on achieving goals and KPIs;
• Making presentations and providing product demonstrations;
• Liaising with distributors ensuring efficient and linear process and relations with authorities;
• excellent service orientation;
• Organising meetings with authorities and partners;
• Organising internal meetings with regional and headquarters for ongoing projects and future plans;
• Updating the activity logs on regular basis;
• Assist Regulatory Affairs department with project management;
• Successfully launched new products receiving sale order for the first time in seven years;
• Consistently achieving set targets within private and government sector;
Abbott Laboratories, Cairo, Egypt
Medical Representative September 2006 - August 2007
Duties: • Arranging appointments with physicians and other medical professionals;
• Promoting and marketing company products;
• Liaison and developing rapport with clients;
• Research market and stay updated on market and competitor developments;
Retail Pharmacy, Cairo, Egypt
Pharmacy Manager January - November 2006
Duties: • Managing the day-to-day operation of the store;
• Advising customers on medical products for their specific conditions;
• Resource planning and management;
• Product order and finance planning;
Scope Company, Cairo and Delta, Egypt.
Sales Coordinator September - December 2005
2012 - 2014 - MBA - Strathclyde Business School, UK
1999 - 2006 - BSc Pharmacy - Egypt