Resume last updated: 16-Sep-15 12:54:00 PM Page 1 of 4

Ahmed Muhammad Farag Address: Darna Compound, Building 26, Flat No. 94, Beside

Carrefour Ma’adi, Ma’adi, Cairo, Egypt Cell: 002 0100 250 7034 e-mail: ahmed.m.farag@outlook.com

PERSONAL DATA

Date of Birth: 20th of March 1984 Place of Birth: Cairo, Egypt Marital status: Married and have 2 children Military Service: Exempted Driving license: Valid Nationality: Egyptian Relocation: Able to relocate

SUMMARY

A Pharmacist with 10 years of experience in regulatory affairs & compliance in both local and multinational companies, generics & Innovative products for the whole Middle East and Africa region, also I am experienced in other different fields of pharmaceutical industry (e.g. Quality Assurance, Quality control, Sales, Marketing, and Market access), with strong interpersonal skills reflecting presentation, communication, and analytical thinking with creative ability coupled with eagerness to learning and innovation, with high approach for problem solving, conducting skillful negotiations, and establishing good relationships with customers (internal and external). Specialties: - Regulatory affairs & regulatory strategic planning - CMC strategic planning (Especially for stability study protocols) - Market access - Quality & compliance management

EMPLOYMENT

Regulatory Affairs Regional Strategy Manager, Africa & Middle East Region (AfME) Pfizer Inc., Egypt 01 July 2013 – Still - Lead, manage and provide strategic direction and oversight to the AfME based regulatory teams to

successfully develop and execute regulatory strategies and plans for cross-regional AfME aspects. - Collaborate with other team leaders and assist AfME Strategy Head in development of regulatory

strategies to support the registration of NCEs, LEs, as well as lifecycle maintenance across the Middle East region in coordination with the Country RA Heads.

- Set & implement the strategy & plans of submissions in the whole region including price assessment, labeling management strategy, etc…

- Manage the CMC strategic planning (e.g.: stability study protocols, Multiple manufacturers, etc…) with global CMC colleagues

- Provide regulatory support necessary to subsidiaries or agents in Africa and Middle East in obtaining new MAs in accordance with each market local regulations as per the objectives & plans set,

- Fulfill local health authorities queries in realistic timelines to grant approvals - Product life cycle maintenance including renewal and different types of variations (type I & II variations) - Review & approve the mockups & relative labeling text included in the promotional materials in the

whole region by processing manual review along with different types of text verification tools - Review & approve the promotional materials in accordance to each local market regulations - Ensure quality performance for key/managed projects & liaise with global team to support global

projects and also to ensure compliance with relevant organizational and Global Regulatory Affairs SOPs - Manufacturing sites registration & license maintenance in concerned markets in AfME - Monitor the team to update the regulatory requirements database for the AfME

Regulatory Affairs Regional Strategist - Africa & Middle East Region (AfME) Pfizer Inc., Egypt 01 Jun 2012 – 30 June 2013 - Same as current with exception of managerial responsibilities

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Drug Regulatory Affairs And Quality Compliance Associate Novartis Pharma, Egypt 13 Dec 2010 – 30 May 2012 - Submits NDA (including NCE, Vaccines, Oncology & Generics) to local HA - Submission of drugs due for renewals - Managing submissions & approval strategy in Egypt including submission plans, labeling management

strategy, CMC review as per the local requirements etc - Building DRA online data on share point 2010 (Microsoft web based sharing tool). - Submission of different types of variations (label updates, manufacturing site transfer, pack size

addition, PPM variation, etc) - Dealing with different CTD & eCTD files to extract local required documents for NDA - Reviewing and assessing the Quality, clinical & non clinical parts of the dossiers - Review & approve the mockups in addition to basic succinct statements in the promotional materials by

processing manual reviewing in addition to different types of text verification tools - Review & approve the promotional materials in accordance to local HA regulations - Requesting reference standards, related substances, HPLC columns required for analysis of the drug

product from global team - Following up with official Labs for product analysis - Preparing and updating regulatory registration SOPs

Drug Regulatory Affairs Associate International drug agencies for pharmaceutical industry "IDI", Egypt 01 Jan 2010 – 12 Dec 2010 - Submits Generics NDA to local HA - Submission of drugs due for renewals - Managing submissions & approval strategy in Egypt including submission plans, labeling management

strategy, CMC review as per the local requirements etc - Submission of different types of variations (label updates, manufacturing site transfer, pack size

addition, PPM variation, etc) - Requesting reference standards, related substances, HPLC columns required for analysis of the drug

product from purchasing department - Following up with official Labs for product analysis - Preparing and updating regulatory registration SOPs

Drug Regulatory Affairs Associate Mepaco – Medifood, Egypt 10 Feb 2009 – 31 Dec 2009 - Same as IDI

Quality Assurance Associate Mepaco – Medifood, Egypt 01 Nov 2007 – 09 Feb 2009 - Maintaining master documents, including manufacturing records/procedures, analytical procedures,

specifications, and SOPs - Receiving, coordinating, documenting, and responding to complainants and closing product quality

complaints for drug - Ensure quality of different production stages for all products by following up on the in-process

production stages including the dispensing of the raw materials until obtaining the finished product - Ensure the product compliance in terms of manufacturing process by sticking to the master batch record - Validation of cleaning, analysis, and manufacturing process

Pharmacist, Pharmacy Manager El-Razaz pharmacy, Egypt 01 Jun 2007 – 31 Oct 2007 - Dispense prescriptions & ensure patients' safety - Dispensing OTC drugs - Hiring & Managing staff - Inventory management, stock evaluation, calculation and request - New drugs data entry - Managing expired drugs

Pharmacist, Shift Manager Gesr El-Seuis pharmacy 01 Jun 2006 – 30 May 2007 - Dispense prescriptions & ensure patients' safety - Dispensing OTC drugs

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- New drugs data entry

Marketing Coordinator & Sales Representative Imprint advertising agency, Egypt 01 Dec 2005 – 30 Apr 2006 - Help in creating product slogan and campaign ideas - Designing and executing direct email campaigns - Offer new promoting ideas and materials on marketing staff in pharmaceutical companies to help them

in identifying the selling point

Medical Representative Egypharma, Egypt 01 Sep 2005 – 30 Nov 2005 - Arranges appointments with doctors, pharmacists and hospital medical teams, which may include pre-

arranged appointments - Increases sales and market share of products through effective territory management and sales

execution - Follows up with various pharmaceutical sales channels (Distributors, Pharmacies, etc) - Establishes strong relationships with healthcare professionals (e.g. physicians, private hospitals,

pharmacies, teaching hospitals) through one-on-one sales presentations, group discussions and medical meeting exhibits

- Develops and implements creative strategies in key accounts and key opinion leaders (KOLs) - Regularly attends company meetings, technical data presentations and briefings

EDUCATION

Pre-Master's Degree, Quality Management Arab Academy for Science, Technology and Maritime Transport Oct 2008 – Oct 2010

Bachelor's Degree, Pharmaceutical Science Faculty of Pharmacy, Cairo University Sep 2001 – May 2005

CERTIFICATES

Decisions and Risk Pfizer, Egypt Nov 2013 Basics of Six Sigma Projects and Teams Pfizer, Egypt Sep 2013 Interpersonal Communication: Communicating Pfizer, Egypt July 2013 With Confidence Lead Management Pfizer, Egypt July 2013 Harvard Manage Mentor - Presentation Skills Pfizer, Egypt Jun 2013 Dynamics of Leadership Pfizer, Egypt Jun 2013 Effective Innovation Leadership Pfizer, Egypt Jun 2013 Appraising Performance Simulation Pfizer, Egypt Jun 2013 Coaching with confidence simulation Pfizer, Egypt Jun 2013 Communication skills and project management Pfizer, Egypt Jun 2013 Business grammar & writing (5 certificates) Pfizer, Egypt Jun 2013 TOEFL test (Score 590) Cairo Univ. - Center of Foreign Aug 2010 Languages and Professional Translation, Egypt e-CTD manager program submission (Extedo) SOSSD, Egypt May 2010 CTD & e-CTD authority SOSSD, Egypt Oct 2009 CTD & e-CTD manager basics SOSSD, Egypt Sep 2009 Uncover counterfeit and promotional claims SOSSD, Egypt Sep 2009 Unified product name selection SOSSD, Egypt Sep 2009 ISO 9001 requirements EQE, Egypt Mar 2009 Lean value stream mapping Symbios Consulting, Egypt July 2008 Inventory management Symbios Consulting, Egypt Jun 2008 Shape your future Pharmacists syndicate, Egypt July 2005 Biotechnology course Faculty of Pharmacy, Cairo July 2005 Univ., Egypt Quality Control training GSK, Egypt Aug 2004

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LANGUAGES

- Arabic: Mother tongue - English: Fluent - French: Basic

COMPUTER

Computer user since 1993: - Different operating systems: Expert in MS Dos, MS Windows and Linux - Different versions of Microsoft office: Expert in Word, Excel & Power Point, professional in Access - Regulatory systems at Novartis & Pfizer: Expert - Different versions of Microsoft Visio and Project: Professional - Document management: Expert in Adobe acrobat professional, Adobe LiveCycle designer - Artwork and design: Professional in Macromedia flash, ACDsee and Photoshop

Internet user since 1998: - Internet exploring & surf and web search: Expert in different types of internet exploring programs

(Microsoft internet explorer, Mozilla Firefox, Google chrome, etc) - Mailing programs: Expert in different versions of Outlook & Lotus notes - Microsoft share point: Expert in different versions - Web design and html & xml languages programming: A good background

SKILLS

- Proven people management & lead skills - High affinity to deal with software systems - High affinity to team work - Active thinking and creativity - Hard worker, good listener & fast learner - Self-discipline, ambitious, cooperative and popular - Good ability of talking and making good relationships