Profile Overview:

13 years experienced pharmacist with a diversified expertise and a high exposure to the medical registration and regulatory issues as well as deep understanding of the registration requirements and procedures of the MENA Ministries of Health.

 Professional Exposure:

Regulatory Affairs & Pharmacovigilance Manager- MENAT- Aspen HealthCare –Dubai -UAE Dec 2020 – Present

• Lead and influence regulatory interpretation, product labelling, implementation of compliance strategies, as well as projects leadership, employee supervision, training and Drive optimization effectiveness of internal processes/procedures and best practices.
• Provide regulatory guidance to compiling/reviewing new product registration and variation dossiers for submission to the relevant regulatory agencies.
• Identify regulatory projects requirements and scope of work and develop project
• Precisely communicate regulatory information to multiple departments and ensure that information is interpreted
• Interacts with internal and/or external stakeholders/clients. Identifies and responds appropriately to issues, providing adequate solutions.
• Review all submission application to regulatory agencies across MENA ensuring timeliness are met, accuracy, comprehensiveness, or compliance with regulatory
• Ensure that the team keep abreast of current data, trends, regulatory knowledge, developments and advances in the regulatory environment.
• Ensuring regulatory team professional development, performance appraisals and employee counselling/mentoring needs are met
• Assimilate regulatory requirements by coordinating projects involving new products, markets, systems and strategies and reviewing, updating, archiving and publishing policies, standards and
• Work cross functionally on new products launches and products acquisition with the new business development and commercial
• Support with all Pharmacovigilance activities with regards to Good Pharmacovigilance Practices (GVP) in alignment with the strategy defined by the business and Aspen Healthcare
• Manage the generation of PV Master Files according to each market requirements on MENA level
• Manage the submission of serious adverse reaction reports, PSURs and Post-authorization Safety Study (PASS) in cooperation with MAHs and reports to Ministry of health as
• Mange the implementation of Global and local SOP’s and how to respond to requests for information from regulatory authorities
• Manage Local reporting and communication with Company EU QPPV (APTL) and cooperate compliance
• Manage Local reconciliation Adverse and serious drug reactions on MENA level with the Marketing Authorization
• Manage the necessary local literature review on MENA level with
• Manage the necessary process to generate, update and finalize SDEA agreements with
• Train Staff to perform Pharmacovigilance related activities. This includes not only staff within the Pharmacovigilance units but also staff who may receive or process safety reports, such as sales personnel, distributors,..etc. Provide a brief description of the training system and indicate where the training records, Curricula Vitae (CVs) and job
• Internal Audit for currently signed SDEA with

Senior Regulatory Affairs & Labelling Associate MENAT- Aspen HealthCare –Dubai -UAE May 2017 – Dec 2020

• Work with market regulatory lead to develop a detailed understanding of regulatory guidelines and technical requirements in assigned countries.
• Files compilation and follow up on the submitted
• Meet the planned submissions dates and ensure continuity of the
• Feed the trackers with accurate information and ensure regular
• Coordinate and prepare renewal of regulatory certificates/ post approval
• Ensure that locally prepared submission packages go through the required quality control check (QC) to ensure they are formatted properly and contain all required elements to meet local regulatory and scientific / technical
• Act as a link between the global organization and the regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate local
• Ensure a proper archiving for any submitted
• Provide assessment/ input for the regulatory projects rolled out by different Aspen
• Work on assigned projects to assist other affiliate where needed based on the business
• Promotional materials review/approval and coordination with marketing and medical

Labelling Responsibilities:

• Act as the MENA superuser of Aspen’s AW management system;
• Gather specifications needed for the execution of packaging
• Supervise the full life- cycle of packaging artwork creation and
• Work closely with other teams and stakeholders to coordinate the whole process from concept/creation to artwork release.
• Mockups creation to support various types of submissions and production Artwork creation post Health authority’s approval (either on Pulse or with 3rd party partners).
• AW Quality control ensuring the proper revision and editing of English content as well as the Arabic translation to have robust
• Provide the affiliates across MENA with the necessary support with regards to artworks creation/ modification where
• Plan for the appropriate timelines of receiving and dispatching all requested
• Coordinate and follow up during product review till approvals of all ongoing projects are
• Create and maintain a shared tracker for all the ongoing changes for the

Regulatory Affairs Officer ME- Pfizer Consumer Healthcare – Dubai- UAE September 2015 – April 2017

Responsible for the full renewals and variations processes and support new registrations of Pfizer Consumer Healthcare products in the ME markets, including the submission of all the governmental requirements & studies according to the guidelines of the Gulf and Levant Markets, covering all aspects technical, administrative& legal processes.

• Development of registration plan for products/markets including local requirements and expected approval
• Provides inputs of anticipated market specific regulatory issues for planned submission inputs/feedback into MENA registration plan for new
• CTD/e-CTD files and market-specific file compilation including preparation of market-specific documents g. application forms, summary sheets and clarification letters.
• Follow-up with the regulatory authority during submission review and ensure all questions /requests are provided/clarified within due time to ensure timely approval of
• Ensure that all marketed products in the country are in compliance with local and corporate regulatory requirements, e. labelling (Product Information and packaging development); label change management; chemistry and manufacturing commitments that were registered with the MOH.

• Ensure local label creation will meet local and corporate criteria by providing the necessary
• Tracking of regulatory
• Ensure that manufacturing sites & MAH are registered in markets that require site
• Archive and maintain records according to local, global SOP’s.

Senior Regulatory Affairs Coordinator – UGP (Hospira-a Pfizer company- Agent in Egypt) March 2011 – May 2014

Regulatory Affairs:

• Ensure submitted product documents will fully meet the local regulatory requirements of CAPA – Egypt for imported finished products.
• Achieve products registration and pricing for new products as per agreed
• Act as first point of contact with regulatory
• Maintain regular contact/relationship with key regulatory officials
• Maintain contact and liaise with key business partners, internally and

Pharmacovigilance:

• Set up, maintain and update the pharmacovigilance system including collecting, evaluating and report information of adverse reactions/medicinal product risks, and coordination of the necessary
• Establish and maintain the Market Authorization Holder’s (MAH) Pharmacovigilance System.
• Ensure the timely response of Egyptian Pharmacovigilance Center requests of any information required for the evaluation of the benefits.
• Act as a single point of contact for Egypt’s regulatory authority on a 24-hour basis and provide the contact point for pharmacovigilance

Regulatory Affairs Specialist – Jedco International Pharmaceuticals Co. – Cairo-Egypt March 2010 – March 2011

• Submission of product documents to meet the local products registration requirements of CAPA (Central administration for Pharmaceutical Affairs)-Egypt.
• Maintain contact and liaise with regulation authority to continuously monitor and update the product’s status under

All technical procedures of locally manufactured drugs registration and submission of different required studies according to the guidelines of the Egyptian Health authority.

Quality Control Analyst – Jedco International Pharmaceuticals Co. –Cairo-Egypt July 2008 –March 2010

• Raw material C
• Packaging material C.

• Finished Product C
• Microbiology C

Community pharmacist – Dr. Raaid Mohammad pharmacy – Cairo- Egypt July 2007- July 2008

 Academic Qualifications:                                                                                                                                    

• Bachelor of Pharmaceutical Sciences – [Ain Shams University] – 2007

Grade: Very Good with Honour

 Personal and other skills:

• Analytical thinking that leads to smart
• Able to work in a flexible team
• Able to communicate to various levels of understandings ensuring that clear messages are delivered both verbally and
• Problems solving and goals achieving
• Continuous learning and acquiring of new skills either professional or

 Languages:

• Arabic: Native Speaker
• English: Fluent
• French: Intermediate-advanced

 IT Skills:

• Microsoft
• Microsoft office (MS Excel, MS Word & MS Power Point)
• Internet & e-mail

References are available upon your respectable request.