SARA S.

► Managed Regulatory Affairs strategy plans for successful registrations across the territory the Middle East and Africa regions. ► Executed all regulatory activities of assigned products including new drug Introduction, life cycle management and transfer of the newly acquired products in the region. ► Designed and set submission strategies and project management to ensure execution of the registration plan in collaboration with GRA Team, local RA staff and local distributors. ► Kept close communication with central teams of GRA, CMC team and third parties to prepare the necessary documentation for all regulatory activities. ► Foster relations with local RA staff and local distributors to prepare the necessary documentation for the regulatory submission and to ensure smooth successful submissions based on the business priority. ► Liaised with Labeling Manager to create ,develop and revise product packaging by following with the local regulations and in alignment with Company policies and procedures. ► Performed cross-functionally on new products launches and products acquisitions, build stronger relationships with relevant internal and external stakeholders. ► Identify changes and modifications in the healthcare regulatory environment and communicate those changes to appropriate individuals and departments for implementing into the organization’s processes. ► Ensured the compliance of database systems content. ► Provided solutions to challenges and responds appropriately to issues. ► Draw up and reviewed budget and drug registration timeline. Key Achievements ► Played a huge role in building the company product portfolio, ► Improved the company’s relations with regulators and contacts throughout the industry via strong communication, and represented the company. ► Implemented a pricing strategy and made strong negotiation to optimize the commercial potential of the products. ► Singlehandedly took and addressed major regulatory issues for the company.

(GSK/Novartis Integration Project & GSK/Pfizer Integration Project) ► Oversaw all regulatory activities including new registrations, MAH change and maintenance activities (Renewals & variations) of products in the wide geographical territory of the Gulf, Middle East and developing markets, with its variety of regulations. ► Liaised closely with central teams of GRA or any third party, and LOC staff to prepare the necessary documentation for the regulatory submission of MAH transfers. ► Lifecycle management activities (variations & renewals): Maintained the Licenses by ensuring the preparation and submission of any variation affecting the products, and timely renewals package preparation and submission at the LOC level. ► Record transfers: Prepared the LOC regulatory records in the appropriate format (electronic, paper) to be transferred to third parties. ► Ensured the compliance of database systems’ content, performs data maintenance activities, updates accurately. ► Pack Management: Updated or created packaging components according to the relevant country regulations and specificities, performing the daily work on the PASS system. ► Carried out administrative activities where necessary to ensure the effective operation of the department. Help implement division goals and objectives.

► Led all regulatory activities including new registrations, MAH change and maintenance activities (Renewals & variations) of products in the wide geographical territory of the Gulf, Middle East and developing markets, with its variety of regulations. ► Ensured fast registration, updating existing files through continuous coordination between RA teams and agents, as well as health authorities. ► Developed and maintained a product database of all products’ regulatory status in the region and ongoing registration, Defined the priority of each project (product - market) based on corporate strategy and Regional Specificities. ► Implemented the regional drug safety and Pharmacovigilance policies, in line with local and international Regulations, Corporate guidelines and the regional policy. ► Followed and applied compliance guidelines and directives as identified by both the local & Global Headquarters. ► Established and maintain good relationships with the Ministry of Health, Regulatory authorities and Pharma associations, ensuring optimum visibility, and priority for product registration. ► Controlled timelines (submissions - approvals- introductions) to cope with regional plans & strategies as well as production plans and capacity through proactive communications with all relevant parties including RA, Packaging and SCM. ► Reviewed artwork and labeling for acceptability with regulations and registered details.

► Responsible for Merger-related Activities in the region of Gulf, the Middle East and developing Markets. ► In charge of maintenance of filings pertinent to Mergers, legal entity Changes, Site transfer and Artwork changes. ► Controlled timelines (submissions - approvals- introductions) to cope with regional plans & strategies as well as production plans and capacity through proactive communications with all relevant parties including RA and Packaging. ► Reviewed artwork and labeling for acceptability with regulations and registered details. ► Archived all regulatory documentation including submissions & approval. ► Responsible for Updating database & Systems highlighting mergers related timelines.

► Dispensed medication with proper labeling, and instructions regarding the usage, dosage and information on side effects as well as precautions. ► Supplied medication to inpatient via the nursing units as per standards and guidelines. ► Provided drug information to doctors and other health care professionals where required, citing proper references. ► Participate in drug utilization review program. ► Communication and information flow are maintained on inter -and intra-department level.

► Dispensed in and out-patients prescriptions. ► Screened orders for discrepancies, prepared medication for stat orders and unit dose bin. ► Prepared extemporaneously compounded medications. ► Worked in I.V room (TPN, I.V additives and antibiotics). ► Performed in unite dose system. ► Trained new pharmacist and technicians. ► Assisted in controlling expired stocks, maintained stock levels and partaking in inventory. ► Monthly inspection of floor stock of dermatology, Ob/Gyn clinics and ward for expiry dates and overstocking.