Michael Abdou Email & Phone Number

Egypt

Cairo, Egypt

Job description Manage a team of several regulatory affairs officers Maintain current knowledge of regulatory standards within jurisdictions of business activity Provide project team with regulatory input in order to obtain timely regulatory approvals Manage the final submission for product approval. Preparation and submission of regulatory.

• Keeping abreast of current regulatory knowledge, trends, developments, international legislations & guidelines including CTD organization, structure and format.
• Regular follow up on latest procedures for development, preparation, and successful submission of CTD and their applicability to products authorization and lifecycle management.
• Preparation of regulatory documentation required for registration of the company’s new products and maintenance of existing ones
• Interfacing with other departments to provide regulatory advice and obtain the necessary documents in accordance with regulatory authorities rules and regulations
• Submission of required documentation to regulatory authorities within the specified timeframe and responding to questions in order to ensure receiving approvals within the shortest timeframe possible
• Taking part in coordinating, planning, scheduling, preparing and assembling of some regulatory projects and submissions.

• Preparation, assembly & presentation of documentation required for submission to national regulatory authorities in order to register the company’s new products and maintain existing registrations.
• Proper documentation, tracking and storage of regulatory documents

• Promoting/selling/securing orders from existing and prospective customers
• Submitting results reports, such as daily call reports, weekly work plans, and monthly and annual territory analyses
• Establishing, developing and maintaining business relationships with current customers and prospective customers in the assigned territory/market segment to generate new business for the organization’s products/services.
• Performing telephone calls and in-person visits and presentations to existing and prospective customers.
• Researching sources for developing customers and for information to determine their potential.
• Keeping abreast of product applications, technical services, market conditions, competitive activities, advertising and promotional trends.

• Preparation, dispensing and monitoring drug therapy

Master’S Degree, Business Administration And Management, General

Bachelor'S Degree, Pharmaceutical Sciences, Good

High School, Science Section