Ahmed Elyamany, Msc. Email & Phone Number

I have a vision for myself to be one of the prominent leaders in the field of quality management with special focuses on the biotechnological and pharmaceuticals industries. My passion for excelling my work driven me to a conclusion that I have to apply the academic related knowledge to my professional work. So, on the light of that, I believe this dream won’t be accomplished unless incorporating the experiences gained during my professional work, in different quality oriented environments, in a suitable academic frame to sharpen my abilities and expand my knowledge to take a step forward to achieve my dream to be an outstanding leader. I have MSc. degree in Biotechnology from the American University in Cairo (AUC).

Listed skills include Gmp, Quality System, Regulatory Affairs, Pharmaceutical Industry, and 31 others.

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  Regulatory Affairs Section-Head

  Inspire Pharma

  Jul 2006 - Present

  Essential functions include, but are not limited to:For assigned products; Ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities. Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations. Ensures timely, accurate and compliant labeling translations and artwork preparation. Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed. Works alongside the Business Development to support business initiatives. Maintains a positive relationship with internal and external regulatory contactsActivities include, but are not limited to: Tracks process and manages answers to objections from the Agency on products registration and new prices, involving negotiations to achieve best price.Cross-functional activities, as assigned Ensure adequate support to other functions to enable compliance in areas related to regulatory. Provides regulatory guidance and support to the license companies and co-marketing partners as appropriate. Secure timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team. Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.Regulatory environment: Keeps abreast of local and international laws/guidelines. Through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with Inspire interests. Shape the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders. For new regulations, identifies and tracks changes/trends that might impact Inspire business.