Caroline Mamdouh

Experience

• 

  Central Administration of Pharmaceutical Affairs (MOH Egypt)

  Jan 2002 - Jan 2009

  Conduct different analysis techniques required for price setting of pharmaceuticals & food supplements products including cost plus, cost minimization, cost effectiveness & Cost benefit analysis. Perform different regulatory activities including the receipt & assessment of applications for authorization of dietary supplements products, post approval changes & appeals. Receipt and assessment of infant and follow up formulas and submission to relevant committees at National Nutritional Institute.

  • Pricing officer

    Jan 2002 - Jan 2009

  • Dietary supplements and infant formulas registration officer

    Jan 2002 - Jan 2007
• 

  Central Administration of Pharmaceutical Affairs (MOH Egypt)

  Apr 2009 - May 2010

  Head of biologicals registration department

  -Monitor & manage all functions performed by the department including the receipt & review of the applications for registration of biological medicinal products, post approval changes (Variations) & appeals -Organization & coordination of vaccines & blood products scientific committees.-Undertake special projects in the institution development including WHO accreditation steps-Share in development of new regulatory strategies for creating a more transparent regulatory environment

• 

  EVA pharma

  Jun 2010 - Sept 2013

  Regulatory Affairs Section Head

  -Manage RA activities for authorization of the company’s new products & maintenance of the existing ones -Ensure the appropriate implementation of the regulatory management strategies.-Co-ordinate the activities of the RA staff & provide guidance in regulatory issues and procedural recommendations for standard operating procedures

• 

  Eli Lilly and Company

  Sept 2013 - Apr 2016

  Scientific office manager and Regulatory affairs manager Egypt

  -Setting-up regulatory submission plan and ensuring implementation activities & timeframes are aligned with business planning models and various cross-functional activities.-Preparing & filling submission to local regulatory agency for different regulatory activities e.g. new licenses, line extensions, variations, labeling, promotional materials and renewals. -Participating in the local industry groups where applicable. -Building and maintaining an effective communication network with internal / external partners to support business. -Becoming knowledgeable on all aspects of regulatory affairs and national legislation and guidance as well as some areas of the latest regional legislation and/or EU, ICH guidance if applicable.-Using appropriate SOPs as required by Global Regulatory Affairs policies (e.g. Regulatory Quality Systems), local regulations and Good Regulatory Practice. -Representing the scientific office in front of public & governmental authorities in Egypt and performing activities as deemed necessary to conduct the business of the scientific office. عرض أقل

• 

  Sanofi

  Apr 2016 - Aug 2018

  Regulatory Head, Egypt and sudan

  Responsibilities cover Egypt, Sudan and Eritrea, together with managing exportation to Middle East / African countries by providing regulatory support for registration of new products and maintenance of existing ones in case Egypt is the reference country.JD:-Provide the planning and leadership to the Regulatory department by ensuring that appropriate structures, systems, competencies and values are developed.-Assist global team in developing and updating procedures that ensure regulatory compliance. -Develop strategic plans in conjunction with senior management colleagues and through cross-functional teams, to ensure the timely / accelerated entry of new products to the market.-Direct the regulatory process for products requiring governmental approval, including filing necessary applications and handling all government interactions required to accelerate registration of new products and maintain existing ones. -Regular update and maintenance of labeling.-Manage export to Middle East / African countries for which Egypt is the reference country-Ensure that the regulatory department provides a value added function to marketing with regards to promotional materials submission / approval. -Monitor legislative and regulatory activities and lead analysis of legislative actions to determine the potential impact on the organization and develop company positions. -Actively participate in industrial committees and analyze Ministerial correspondence with follow-up and discussion with internal colleagues and other industry participants on relevant issues.-Provide coaching to the regulatory team in various aspects.-Ensure effective team communication throughout the regulatory department through the application of suitable reporting systems and structures and the identification and provision of appropriate training.-Ensure that the interfaces between regulatory and other departments are managed optimally.-Prepare annual regulatory budget. عرض أقل

• 

  Medtronic

  Sept 2018 - now

  Role was extended to cover South Africa and SADC countries

  • Regulatory Affairs and Quality Assurance Director - Africa

    Jan 2024 - now

  • Regulatory Affairs and Quality Assurance Senior Manager - Africa

    Mar 2023 - Jan 2024

  • Regulatory Affairs and Quality Assurance Senior Manager - Emerging Africa

    Sept 2018 - Jun 2023