Sara Mohamed Abdel Khalek

Senior Regulatory Affairs Specialist Serving Middle East & GCCFull Time

• Job Details:▪ Main Responsibilities include: - Understanding the registration requirements for several countries. - Requesting suppliers to provide different documents required for the registration. - Feeding the different governmental systems with the required registration information and uploading needed documents. - Understanding the Comments received from the Authorities on any registration and passing it to the supplier in an easy understandable manner. - Attending Conference calls with suppliers, prioritizing the requirements, conveying the needed tasks in an understandable manner. - Maintaining the Archive system. - Ability to bridge the communications between Authorities/our local agents in the countries with the suppliers. - Follow the internal regulations in Amico. - Other regulatory activities such as classification, prequalification. - Communicating with the legal department in Amico for all legal concerns. - Close follow up for all pending issues - Preparing reports related to the progress of work.

Consultant Regulatory Affairs Associate - MENAFull Time

• Job Details:▪ Main Responsibilities include: ▪ Governance of dossiers’ technical aspects based on the knowledge for existing & emerging regulations. ▪ Validate registration dossiers to ensure compliance with regulatory guidelines. ▪ Compile, Prepare, submit and acquire approval for registration dossiers supporting various regulatory activities including submission and maintenance of marketing authorization (new registration & renewal applications), submission of variations (Labeling & CMC), submission and maintenance of relevant licenses (to import, store and distribute medicinal products) across MENA markets. ▪ Maintain & archive technical documentation, databases, or systems. ▪ Develop internal and external communication channels with different stakeholders to support regulatory projects. ▪ Provide needed regulatory support & advice to different departments: marketing, supply chain, commercial, medical, Pharmacovigilance…etc. ▪ Analyze, prepare, and respond to queries raised by Health Authorities. ▪ Coordinate, create, translate & proofread packaging materials, product information leaflets, and summary of product characteristics in local language as needed. ▪ Maintain contacts with relevant key personnel in local Regulatory Authorities, local representatives, partner companies, and company affiliates. ▪ Analyze, assess and report changes in the regulation guidelines and ensure its communication to relevant stakeholders & implementation in company policies and procedures. ▪ Ensure compliance with local health authorities’ regulation, company policies & procedures. ▪ Maintain knowledge of company products.

Regulatory coordinator - PGSFull Time

• Job Details:▪ Main Responsibilities include: Regulatory strategy development & Implementation for Human pharmaceutical products: ▪ Executes the agreed plans by coordinating dossiers submission within planned timelines for renewals. ▪Handle re-registration process with health authorities for locally manufactured products to secure successful continuation of products in the market. ▪ Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems are followed ensuring training in P2L and PLS are completed 100% (systems and procedures). ▪ Handle any changes in (manufacturing ingredients, packaging materials, artwork, storage conditions & suppliers) with MoH & taking the necessary actions to assure compliance with health authorities, for example: leaflet/packs updates, pack/composition/adding supplier variations submission & implementation). ▪Handle stability/dissolution/bioequivalence studies submissions to MoH to assure compliance. ▪ Manage the completion of Lifecycle (LC) submissions and approvals as per established Regulatory performance metrics ▪ Ensure submitted product documents will fully meet the local regulatory & perform 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 product. ▪ Maintain compliance (GDMS, EPALM, PEARL, CMC change control, product labelling, etc.) at 100%. Archive and maintain regulatory related records according to local, global SOP’s ▪ Develop strong partnerships with in-country (e.g. Country Strategists, Submission and labeling/artwork Hubs, WSR-Team) to facilitate the development and implementation of registration strategies to expedite the renewal of products and life-cycle optimization. ▪ Ensure all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures. ▪ Develop effective relationships with local & global internal partners.